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 .
Election/Restrictions
Applicant's election with traverse of Group 1 (claims 26-28 and 37-49) and Species B, C, and E (claims 38, 42-43 and 47-48 respectively) in the reply filed on 7/13/2026 is acknowledged. The traversal is on the following ground(s):
Traverse
Applicant notes that with respect to at least Species C & D, the Restriction indicates, "Species C & D provide different types of sensors (i.e., position sensors vs. force feedback sensors.)".
Applicant notes that MPEP 806.04(f) states:
Where two or more species are claimed, a requirement for restriction to a single species may be proper if the species are mutually exclusive. Claims to different species are mutually exclusive if one claim recites limitations disclosed for a first species but not a second, while a second claim recites limitations disclosed only for the second species and not the first. This may also be expressed by saying that to require restriction between claims limited to species, the claims must not overlap in scope.
As a non-limiting example, the Restriction has not established mutual exclusivity. As an example, Applicant's Application at para. [0112] states:
the system may include position sensors for discerning the position and movement of the robotic controls. The system may include force feedback sensors to reduce the risk of the robot pushing against tissue structures and causing perforation. The position sensors may also be used for guidance as would be understood by one of skill in the art.
Since, as one example, the position and force sensors may be used during operation by the same system for complementary purposes, Applicant respectfully requests withdrawal of the restriction.
Additionally, the Restriction states, "Species E & F acquire first and second image data, however species F generates and modifies a 3D model based on image data of a portion of an anatomical structure. Species E image data includes information of the entire anatomical structure."
Applicant notes that the Restriction appears to characterize the claims with language not included in the claims. For example, it is unclear where the Restriction finds support for the statement, "Species E image data includes information of the entire anatomical structure."
Applicant therefore respectfully requests withdrawal of the restriction.
Examiner respectfully disagrees, and the traversal is not found persuasive. Examiner respectfully notes that no arguments are made with respect to the restriction between groups I and II, nor between species A and B.
Regarding species C & D, Applicant argues “Since, as one example, the position and force sensors may be used during operation by the same system for complementary purposes, Applicant respectfully requests withdrawal of the restriction” and refers to par [0112] of Applicant’s instant written description. The two types of sensors are used to perform distinct and different functions and may be mutually exclusive; the system may have position sensors for deriving position and motion of the robotic controls, or the system may have force-feedback sensors to detect contact between the robot and the patient’s tissue. As provided in Applicant’s argument, “Where two or more species are claimed, a requirement for restriction to a single species may be proper if the species are mutually exclusive. Claims to different species are mutually exclusive if one claim recites limitations disclosed for a first species but not a second, while a second claim recites limitations disclosed only for the second species and not the first” MPEP 806.04(f). Species C and D are mutually exclusive.
Regarding species E & F, Applicant argues “Applicant notes that the Restriction appears to characterize the claims with language not included in the claims. For example, it is unclear where the Restriction finds support for the statement, ‘Species E image data includes information of the entire anatomical structure’”. Examiner respectfully notes that the claim language, as drafted, supports the restriction statement cited by the Applicant. As discussed in the restriction requirement claims 47-48 (species E) obtain image data related to “at least one anatomical structure” and claim 49 (species F) obtain image data related to “a portion of the at least one anatomical structure” and “a different portion of the at least one anatomical structure”. A ‘portion’ of a structure/element is not the ‘entire’ structure/element. The sources of the ‘image data’ and the processing functions are distinct between the restricted species. Species E & F are mutually exclusive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-25 and 33-36 have been cancelled by Applicant. Claims 26-32 and 37-49 are pending of which claims 29-32, 37, 46 and 49 are withdrawn. Accordingly, claims 26-28, 38-45 and 47-48 remain pending for examination on the merits.
Claim Objections
Claims 26, 38, 47 is/are objected to because of the following informalities:
Claim 26 recites the limitation “and/or”, resulting in the creation of multiple interpretations of this and dependent claims based on the use of “and”, “or”, or both. Furthermore, claim 26 does not appear to be proper Markush type claims. It is suggested to replace all instances of “and/or” with either “and” alone or “or” alone. For the purposes of examination, the broadest reasonable interpretation of the claim was implemented.
Claim 38 recites the limitation “wherein the cradle clamps the catheter handle”. The claim language must be amended to consistently point to structures recited in the claims – the term ‘catheter handle’ must be amended to read ‘imaging catheter handle’.
Claim 47 recites “control the imaging catheter to obtain second image data from a second location in a patient,” which appears to contain a typographical error. It is suggested to amend the claim to recite –the patient– to remain consist with the remainder of the claim.
Appropriate correction is required.
Claim Interpretation
Claim 26 recites the limitations “a. a base adapted to be repositionable along a floor […] wherein the cradle is adapted for translation and/or rotation”. Similarly, claim 27 recites the limitations “an imaging console adapted to receive and process imaging data”. It has been held that the recitation that an element is "adapted to" perform a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense [In re Hutchison, 69 USPQ 138]. It is suggested to amend the limitations to remove the ‘adapted’ terms or to use different terminology consistent with common U.S. practice.
Claim Rejections - 35 USC § 112
35 USC § 112(b)
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.
Claim(s) 26-28, 38-45 and 47-48 is/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. Claims 27-28, 38-45 and 47-48 are also rejected at least by virtue of dependency upon a rejected claim.
Claim 26 recites “a cradle sized and shaped for receiving an imaging catheter handle therein, the cradle comprising one or more actuators positioned to interface with one or more knobs of the imaging catheter handle when the imaging catheter handle is secured within the cradle, wherein the cradle is adapted for translation and/or rotation” which renders the claim indefinite. There is insufficient antecedent basis for the ‘imaging catheter handle’ because it is not clear whether the ‘imaging catheter’ recited earlier in the claim has a ‘handle’; in distinct interpretations there may be a single imaging catheter which has a handle or two ‘imaging catheters’ (one having a ‘handle’ and the other having a ‘middle portion of an elongate shaft’). It is suggested to amend the claim to include all the structural elements of the ‘imaging catheter’ prior to limitations describing the mechanical coupling and interface between the ‘imaging catheter’ and the ‘robotic system’. In addition the clause “wherein the cradle is adapted for translation and/or rotation” is unclear because the claim language does not specify what is being ‘translated’ or ‘rotated’. In an interpretation the ‘imaging catheter handle’ may be translated/rotated, and in another interpretation the entire ‘cradle’ may translate/rotate. It is suggested to amend the claim language to clarify which structures perform the translation or rotation.
Claim 28 recites "wherein the controller is operatively coupled to the imaging console and is further programmed to cause the movement based on the processed imaging data". There is insufficient antecedent basis for this limitation in the claim. There is no prior recitation of either an ‘imaging console’ or ‘processed imaging data’ in the instant claim 28 nor independent claim 26, and it is unclear what these elements are specifically referring to. It is suggested to amend the claim to alter dependency or to provide proper antecedent basis for the unsupported elements.
Claim 38 recites “wherein the cradle clamps the catheter handle for control of rotation thereof”, which renders the claim indefinite. As discussed in the rejection to claim 26 above, it is unclear what ‘rotation’ is being performed (e.g., ‘cradle’ rotates, ‘catheter handle’ rotates, both/neither structures rotate, etc.). It is suggested to amend the claim to clearly define claim elements and the functions being performed.
Claim 39 recites “wherein an extendable track supports a middle portion of the imaging catheter and controls catheter depth”; there is insufficient antecedent basis for this limitation in the claim. It is not clear if the ‘middle portion of the imaging catheter’ refers to the ‘middle potion of an elongate shaft of the imaging catheter’ as recited in claim 26 or to another ‘portion’. For the purposes of examination, the broadest reasonable interpretation of the limitation is any ‘portion’ of the imaging catheter.
Claim 40 recites “wherein a generally annular interface is positioned at the end of a multi-axis adjustable arm to move the imaging catheter in an X-Y plane” which renders the claim indefinite. The term “generally” is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how ‘annular’ the interface is structured to be ‘generally annular’ – there is no scale or metric defining how ‘ring-shaped’ or ‘round’ the interface may be. It is suggested to amend the claim language to remove or define relative terms. Claim 40 also recites the limitation "a multi-axis adjustable arm to move the imaging catheter in an X-Y plane". There is insufficient antecedent basis for this limitation in the claim. It is not clear if the ‘multi-axis adjustable arm’ is referring to the ‘arm comprising an interface’ recited in claim 26, or if it is referring to another distinct arm for moving the imaging catheter. For the purposes of examination, the broadest reasonable interpretation of the claim limitation may be any ‘arm’ as discussed above.
Claim 41 recites “a robotic arm supports a middle portion of the imaging catheter and controls the position of the elongate shaft with respect to a patient's mouth via a pulley wheel”; there is insufficient antecedent basis for this limitation in the claim. It is not clear if the ‘robotic arm’ and ‘middle portion of the imaging catheter’ refers to the ‘arm’ and ‘middle potion of an elongate shaft of the imaging catheter’ as recited in claim 26, or to another ‘robotic arm’ and ‘portion’. For the purposes of examination, the broadest reasonable interpretation of the limitations ‘robotic arm’ and ‘middle portion’ are applied to the claim language.
Claim 42 recites “further including position sensors for discerning the position and movement of robotic controls” which renders the claim indefinite. It is not clear what the position sensors are specifically ‘discerning’, nor what the ‘robotic controls’ are specifically pointing to. In an interpretation the ‘robotic controls’ may refer to the limitation “the controller programmed to cause movement of the 1) arm, 2) cradle, and/or 3) cradle actuators” in claim 26, wherein the ‘robotic controls’ are the ‘arm’, ‘cradle’, and/or ‘cradle actuators’. In another interpretation the ‘controls’ refer to the programming which causes movement, or to another distinct input (e.g., user, remote, etc.). It is suggested to revise the claim language to clearly define what the ‘robotic controls’ are, to clearly point out which structures the position sensors are ‘discerning’ and the disposition of the position sensors on the robotic system.
Claim 48 recites “determine a correspondence between the third image data and the 3D anatomical model; identify a discrepancy between the at least one anatomical structure in the third image data and the associated at least one structure in the 3D anatomical model; and update the 3D anatomical model based on the discrepancy” which renders the claim indefinite. There is insufficient antecedent basis for the limitation in the claim. There is no prior recitation of a ‘3D anatomical model’ in the instant claim 48 or in the claims upon which it depends. It is also not clear what ‘the associated at least one structure’ is referring to. It is suggested to review and amend the claim language to properly recite the claimed elements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 26-28, 38-45 and 47-48 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (WO2021127426A1, 2021-06-24; hereinafter “Zhang”) as provided by Applicant.
Regarding claim 26, Zhang teaches a robotic system for use in control of an imaging catheter (“A robotic endoscopic apparatus” [clm 1]; “the system may further include a support apparatus such as a robotic manipulator (e.g., robotic arm) […] the support apparatus may be a hand-held device or other control devices that may or may not include a robotic system. In some embodiments, the system may further include peripheral devices and subsystems such as imaging systems” [56]; [fig. 2A-2B, 5-12, 17-18G]), the robotic system comprising:
a. a base adapted to be repositionable along a floor within an operating room, wherein the base comprises lockable wheels (“the treatment control system may include or be integrated with a robotic support system 605 including the robotic arm 607, […] The irrigation and aspiration systems 601, 603 may reside on a robotic arm base cart” [83]; “a robotic arm 710 mounted on top of a robot cart in a treatment control system. The robotic arm 710 may automatically position the catheter assembly to an initial position (e.g., access point) to access the target tissue” [84]; [fig. 2A-2B, 5-12; see fig. 6B reproduced below]);
b. an arm movably coupled to the base, the arm comprising an interface for receiving a middle potion of an elongate shaft of the imaging catheter (“a disposable elongate member comprising: a proximal end and a distal end, wherein the proximal end is removably attached to a robotic arm via a handle, wherein the distal end is integrated with an imaging device,” [clm 1]; “the system may further include a support apparatus such as a robotic manipulator (e.g., robotic arm) to drive, support, position or control the movements and/or operation of the elongate member” [56]; “the robotic bronchoscopy system 200 may comprise a steerable catheter assembly 220 and a robotic support system 210, for supporting or carrying the steerable catheter assembly” [63]; [fig. 2A-2B, 5-12; see fig. 6B reproduced below]);
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Treatment control system comprising robot arm 607 disposed on wheeled cart base, wherein instrument driving mechanism facilitates control of catheter (Zhang [fig. 6B])
c. a cradle sized and shaped for receiving an imaging catheter handle therein, the cradle comprising one or more actuators positioned to interface with one or more knobs of the imaging catheter handle when the imaging catheter handle is secured within the cradle, wherein the cradle is adapted for translation and/or rotation (“The catheter may be steered or advanced towards the target site […] the movement of the catheter may be image guided such that the insertion and/or steering direction may be controlled automatically” [60]; “The instrument driving mechanism may provide mechanical and electrical interface to the steerable catheter assembly 220. The mechanical interface may allow the steerable catheter assembly 220 to be releasably coupled to the instrument driving mechanism” [63]; “The instrument driving mechanism may be used to control the elongate member or robotic bronchoscope in two or more degrees of freedom (e.g., articulation).” [83]; “an instrument driving mechanism 920 providing mechanical interface to the handle portion 913 of the robotic bronchoscope. […] the instrument driving mechanism 920 may comprise a set of motors that are actuated to rotationally drive a set of pull wires of the catheter. The handle portion 913 of the catheter assembly may be mounted onto the instrument drive mechanism so that its pulley assemblies are driven by the set of motors” [88]; [fig. 2A-2B, 5-12]); and
d. a controller operatively coupled to the arm and the cradle, the controller programmed to cause movement of the 1) arm, 2) cradle, and/or 3) cradle actuators to adjust a position of the imaging catheter or a configuration of a knob thereof (“One or more methods or operations disclosed herein can be implemented in hardware components or combinations of hardware and software such as, for example, ASICs, special purpose computers, or general purpose computers.” [54]; “The steerable catheter assembly 220 may comprise a handle portion 223 that may include components configured to processing image data, provide power, or establish communication with other external devices. […] The handle portion may be in electrical communication with a modular wireless communication device or any other user device (e.g., portable/hand-held device or controller) for transmitting sensor data and/or receiving control signals.” [64]; “the bronchoscope system may include a treatment interface module 231 (user console side) and/or a treatment control module 233 (patient and robot side). The treatment interface module may allow an operator or user to interact with the bronchoscope during surgical procedures” [66]; “an instrument driving mechanism 920 providing mechanical interface to the handle portion 913 of the robotic bronchoscope. […] the instrument driving mechanism 920 may comprise a set of motors that are actuated to rotationally drive a set of pull wires of the catheter. The handle portion 913 of the catheter assembly may be mounted onto the instrument drive mechanism so that its pulley assemblies are driven by the set of motors” [88]; [fig. 2A-2B, 5-12]).
Regarding claim 27, Zhang teaches the robotic system of claim 26,
Zhang further teaching further comprising an imaging console adapted to receive and process imaging data from the imaging catheter (“a display configured to display image data captured by the imaging device overlaid with virtual renderings of one or more components” [clm 16]; “the provided bronchoscope system may also comprise a user interface. As illustrated in the example system 230, the bronchoscope system may include a treatment interface module 231 (user console side) and/or a treatment control module 233 (patient and robot side)” [66]; “a view of the real-time fluoroscopic image/video 407 may also be displayed on the graphical user interface. In some cases, users may also be permitted to access the camera view or image/video 411 captured by the bronchoscope in real time” [73]; [fig. 2A-12]).
Regarding claim 28, Zhang teaches the robotic system of claim 26,
Zhang further teaching wherein the controller is operatively coupled to the imaging console and is further programmed to cause the movement based on the processed imaging data (“The instrument driving mechanism may be provided by any suitable controller device […] The instrument driving mechanism may provide mechanical and electrical interface to the steerable catheter assembly 220” [63]; “the provided bronchoscope system may also comprise a user interface. […] the bronchoscope system may include a treatment interface module 231 (user console side) and/or a treatment control module 233 (patient and robot side)” [66]; “The imaging device and the illumination device may be integrated to the catheter. […] the attitude or orientation of the imaging device may be controlled by controlling a rotational movement (e.g., roll) of the catheter.” [100]; “as each pull wire is individually connected to the distal portion and individually controlled, the articulation force may be dynamically adjusted according to different pull wire configurations. […] the control signals for controlling the pull wires may be dynamically adjusted based on the available pull wires in case of a pull wire is broken” [108]; The controller may transmit control signals for controlling the motion of the catheter and adjusting pull wires [fig. 2A-2B, 5-12], [see claim 26 rejection]).
Regarding claim 38, Zhang teaches the robotic system of claim 26,
Zhang further teaching wherein the cradle clamps the catheter handle for control of rotation thereof (“The mechanical interface may allow the steerable catheter assembly 220 to be releasably coupled to the instrument driving mechanism” [63]; “The instrument driving mechanism may provide mechanical and electrical interface to the robotic bronchoscope 820. The mechanical interface may allow the robotic bronchoscope 820 to be releasably coupled to the instrument driving mechanism.” [87]; “the instrument driving mechanism 920 may comprise a set of motors that are actuated to rotationally drive a set of pull wires of the catheter. The handle portion 913 of the catheter assembly may be mounted onto the instrument drive mechanism so that its pulley assemblies are driven by the set of motors” [88]; Rotational movement of the catheter is controlled when the handle portion is attached to the instrument driving mechanism [fig. 2A-2B, 5-12], [see claim 26 rejection]).
Regarding claim 39, Zhang teaches the robotic system of claim 26,
Zhang further teaching wherein an extendable track supports a middle portion of the imaging catheter and controls catheter depth (“an anti-buckling mechanism may be coupled to the handle portion of the robotic bronchoscope to support the catheter […] The anti-buckling mechanism 1700 may be a telescopic extending device with internal mechanism to achieve anti-buckling of catheter during the insertion and withdrawal. The anti-buckling mechanism 1700 may be detachably connected to the handle portion of the robotic bronchoscope at one end, and may be detachably connected to a support surface 1701 at the other end.” [114]; [fig. 2A-2B, 5-12, 17-18G; see fig. 17 reproduced below]).
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The anti-buckling telescoping tube is an extendable track which modifies depth of the catheter relative to patient (Zhang [fig. 17])
Regarding claim 40, Zhang teaches the robotic system of claim 39,
Zhang further teaching wherein a generally annular interface is positioned at the end of a multi-axis adjustable arm to move the imaging catheter in an X-Y plane (“A support arm may be supported by the robotic mobile cart that supports the endotracheal tube mount and provides a support surface for the distal end of the anti-buckling tube to press against as it is compressed. The support arm may be controlled to rotate, translate vertically up and down and/or may a boom arm that expands and contracts, such that it can be precisely positioned over the patients mouth and attached to the endotracheal tube mount.” [115]; The ET Tube mount support arm has an annular ring disposed above patient to interface with the imaging catheter and further control catheter positioning [fig. 2A-2B, 5-12, 17-18G], [see claim 39 rejection]).
Regarding claim 41, Zhang teaches the robotic system of claim 26,
Zhang further teaching wherein a robotic arm supports a middle portion of the imaging catheter and controls the position of the elongate shaft with respect to a patient's mouth via a pulley wheel (“the instrument driving mechanism 920 may comprise a set of motors that are actuated to rotationally drive a set of pull wires of the catheter. The handle portion 913 of the catheter assembly may be mounted onto the instrument drive mechanism so that its pulley assemblies are driven by the set of motors” [88]; “the proximal end or portion of one or more pull wires 1105 may be operatively coupled to various mechanisms (e.g., gears, pulleys, etc.) in the handle portion of the catheter assembly. […] operation of the pull wires by the control unit may apply force or tension to the distal portion which may steer or articulate (e.g., up, down, pitch, yaw, or any direction in-between) at least the distal portion (e.g., flexible section) of the catheter.” [95]; “the patient-side connector may be fixed to a patient side mount […] lining up a collapsed anti-buckling mechanism 1845 with the patient-side connector with alignment guidance or feedback” [121]; [fig. 2A-2B, 5-12, 17-18G], [see claim 26, 40 rejection]).
Regarding claim 42, Zhang teaches the robotic system of claim 26,
Zhang further teaching further including position sensors for discerning the position and movement of robotic controls (“a position sensor” [clm 1]; “In various embodiments, the system may track and make use of position information. The catheter position may be monitored with position sensors. The catheter position may be tracked by monitoring the robotic motors” [66]; “position sensors such as electromagnetic (EM) sensors may be used to accurately track the position of the distal tip of the catheter. In some cases, one or more EM sensors 1310 may be disposed at the distal portion […] Electromagnetic coils located on the distal end may be used with an electromagnetic tracking system to detect the position and orientation of the distal end of the endoscope while it is disposed within an anatomical system” [104]; [fig. 2A-2B, 5-12]).
Regarding claim 43, Zhang teaches the robotic system of claim 42,
Zhang further teaching wherein the controller is configured to drive the cradle and the robotic controls (“The steerable catheter assembly 220 may comprise a handle portion 223 that may include components configured to processing image data, provide power, or establish communication with other external devices. […] The handle portion may be in electrical communication with a modular wireless communication device or any other user device (e.g., portable/hand-held device or controller) for transmitting sensor data and/or receiving control signals.” [64]; “an instrument driving mechanism 920 providing mechanical interface to the handle portion 913 of the robotic bronchoscope. […] the instrument driving mechanism 920 may comprise a set of motors that are actuated to rotationally drive a set of pull wires of the catheter. The handle portion 913 of the catheter assembly may be mounted onto the instrument drive mechanism so that its pulley assemblies are driven by the set of motors” [88]; “a pull-wire configuration pattern may be formed and a mapping relationship between the selected grooves/slots and the pull wires may be transmitted to the control unit. Control signals may then be generated during articulation based on the mapping relationship to achieve desired articulation force” [109]; [fig. 2A-2B, 5-12], [see claim 26 rejection]).
Regarding claim 44, Zhang teaches the robotic system of claim 26,
Zhang further teaching wherein the controller incorporates an algorithm and is configured to translate the cradle in incremental steps (“a control of the articulation of the robotic endoscopic apparatus is based at least in part on a virtual mapping algorithm” [clm 20]; “A controller or processor as described herein generally comprises a tangible medium to store instructions to implement steps of a process,” [54]; “the system may further include a support apparatus such as a robotic manipulator (e.g., robotic arm) to drive, support, position or control the movements and/or operation of the elongate member” [56]; “the instrument driving mechanism may be mounted to the robotic arm. The arm may have redundant degrees of freedom allowing for its elbow to be algorithmically, or passively, moved into configurations that are convenient for an operator” [84]; [fig. 2A-2B, 5-12]).
Regarding claim 45, Zhang teaches the robotic system of claim 44,
Zhang further teaching wherein the controller is configured to rotate the cradle as it is translated (“the attitude or orientation of the imaging device may be controlled by controlling a rotational movement (e.g., roll) of the catheter.” [100]; [fig. 2A-2B, 5-12], [see claim 26 rejection]).
Regarding claim 47, Zhang teaches the robotic system of claim 26,
Zhang further teaching wherein the controller is configured to control the imaging catheter to:
obtain first image data from a first location in a patient, the first image data including information related to at least one anatomical structure;
control the imaging catheter to obtain second image data from a second location in a patient, the second image data including information related to the at least one anatomical structure (“The steerable catheter assembly 220 may comprise a handle portion 223 that may include components configured to processing image data, […] the handle portion may be in electrical communication with the instrument driving mechanism 213 via an electrical interface (e.g., printed circuit board) so that image/video data and/or sensor data can be received by the communication module of the instrument driving mechanism and may be transmitted to other external devices/systems” [64]; “The robotic arm 710 may automatically position the catheter assembly to an initial position (e.g., access point) to access the target tissue” [84]; “the imaging device may be a video camera 1113. The imaging device may comprise optical elements and image sensor for capturing image data.” [98]; Real-time imaging data (i.e., first and second image data) of the anatomy and target tissue may be generated during the procedure [fig. 2A-2B, 5-12, 17-18G], [see claim 26 rejection]); and
generate a representation of the at least one anatomical structure based on the first and second image data (“a display configured to display image data captured by the imaging device overlaid with virtual renderings of one or more components” [clm 16]; “during robotic bronchoscope driving, the optimal path 403 may be displayed and overlaid onto the virtual airway model. As described above, the virtual airway model may be constructed based on the real-time fluoroscopic image/video (and location data of the imaging system). […] In some cases, users may also be permitted to access the camera view or image/video 411 captured by the bronchoscope in real time” [73]; A virtual airway model may be generated and updated based on the acquired image data, wherein the image/video data and the virtual airway model may be displayed to the user in real-time [fig. 2A-2B, 5-12, 17-18G], [see claim 26 rejection]).
Regarding claim 48, Zhang teaches the robotic system of claim 47,
Zhang further teaching wherein the controller is configured to
control the imaging catheter to obtain third image data relating to the at least one anatomical structure (“users may also be permitted to access the camera view or image/video 411 captured by the bronchoscope in real time” [73]; “the imaging device may be a video camera 1113. The imaging device may comprise optical elements and image sensor for capturing image data.” [98]; [fig. 2A-2B, 5-12, 17-18G], [see claim 47 rejection]);
determine a correspondence between the third image data and the 3D anatomical model; identify a discrepancy between the at least one anatomical structure in the third image data and the associated at least one structure in the 3D anatomical model; and update the 3D anatomical model based on the discrepancy (“ At a registration step before driving the bronchoscope to the target site, the system may align the rendered virtual view of the airways to the patient airways. Image registration may consist of a single registration step or a combination of a single registration step and real-time sensory updates to registration information. Once registered, all airways may be aligned to the pre-operative rendered airways.” [72]; “a user interface for visualizing a virtual airway 409 overlaid with an optimal path 403, location of the tip of the catheter 401, and lesion location 405. […] the virtual airway model may be constructed based on the real-time fluoroscopic image/video (and location data of the imaging system). In some cases, a view of the real-time fluoroscopic image/video 407 may also be displayed on the graphical user interface. In some cases, users may also be permitted to access the camera view or image/video 411 captured by the bronchoscope in real time.” [73]; Virtual views of airway model are updated in real-time to ensure registration (i.e., determining correspondence and discrepancies) when using the robotic system [fig. 2A-2B, 5-12, 17-18G], [see claim 26 rejection]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zheng et al. (WO2020242491A1, 2020-12-03) teaches a system for endovascular treatment of a blood vessel that includes a control unit, an ultrasound device, an actuator, and a catheter having a treatment portion [abst].
Patriciu et al. (US20210177530A1, 2021-06-17) teaches robots for performing various interventional procedures, and specifically relates to a multi-stage robot attachable to a wall of an anatomical structure (e.g., a heart, a stomach, an intestine and a bladder) for facilitating a target positioning of an end-effector within the anatomical structure [0001].
Moll et al. (US20190350660A1, 2019-11-21) teaches robotically controlled systems, such as telerobotic surgical systems, and more particularly a robotic catheter system for performing minimally invasive diagnostic and therapeutic procedures [0002].
Dupont et al. (US20210236773A1, 2021-08-05) teaches autonomous robotic catheters for minimally invasive procedures within the body, such as brain and cardiac surgeries [0003].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST.
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
Prosecution Insights