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 Objections
Claims 1, 11, and 12 is objected to because of the following informalities:
Claim 1 recites each of “an airway” and “a diameter” twice. Claim 1 should be amended as follows:
determine if the distal end of the EWC is located within an airway having a diameter that approximates an outer diameter of the catheter; and
instruct, if the distal end of the EWC is located within [[an]] the airway having [[a]] the diameter that approximates the outer diameter of the catheter, the drive mechanism to reduce tension on the distal end of the EWC to permit the distal end of the EWC to deflect when contacting walls of the lumen.
Claim 11 should be amended in a similar manner (i.e., with respect to “airway” and “diameter”) as described above for claim 1.
Claim 12 is a dependent method claim that follows independent method claim 11. Claim 12 should read: “The method according to claim 11, further comprising….”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “drive mechanism ” in claims 1, 8, 10, 11, 15, 16, and 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Corresponding structure of “drive mechanism” is described in, for example, paragraphs [0044], [0045], [0066], [0067].
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 5, 11, 12, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publ. No. 2023/0071306 A1 (hereinafter “MILLER”) and U.S. Patent Application Publ. No. 2017/0281288 A1 (hereinafter “WAI AU”) and U.S. Patent Application Publ. No. 2015/0245826 A1 (hereinafter “STOY”).
With respect to claim 1, MILLER teaches a system for performing a surgical procedure. “Aspects of the present disclosure are directed to systems and methods…to accessing and providing therapy to intra-body target tissue during a medical or surgical procedure.” ([0002]). While the illustrated embodiment is directed toward procedures within the
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gastrointenstinal tract, MILLER clearly teaches that the systems and methods may be directed toward endobronchial-type procedures. “In another example, the medical device can be routed through a patient trachea into branches of patient airways to model patient lungs for mucosal resurfacing or ablation for treatment of lung conditions. Individual airway branches can be marked visually during navigation and treatment overlaps can be determined during a procedure such as for treatments for chronic obstructive bronchitis or asthma (for example, using RF ablation, cryospray, plasma energy, ultrasonic waves, microwave, electroporation, etc.).” ([0084]). The system includes:
an extended working channel (EWC), the EWC including a drive mechanism configured to articulate a distal end of the EWC. Figure 1 is shown here. MILLER describes various medical instrument systems having an elongate device 102. The elongate device 102 has “a flexible body 116 and a main lumen 104 (also referred to as a working lumen, main channel, or working channel) and a localization sensor or set of localization sensors, which optionally may be integrated into a wall of the elongate device 102. Alternatively, the localization sensor or sensors may be slideably disposed in main lumen 104 or in another lumen (not shown), or they may be otherwise integrated into the body of elongate device 102.” ([0042]). Either the flexible body 116 or the main lumen 104 teaches the claimed extended working channel, each of which provides a channel for another device and have a distal end. With respect to the claimed drive mechanism, “[t]he elongate device 102 optionally may be coupled to or in communication with a variety of systems, including a kinematic arm manipulator assembly 120….” ([0042]).
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a catheter operably coupled to the EWC, the catheter including a camera and an electromagnetic (EM) sensor. Figure 10 shows another example of an elongate device. The elongate device 1002 includes a flexible body 1016 (i.e., working channel) having a distal end portion 1018 and a main lumen 1004 (i.e., another working channel). The device may also have catheters 1022 or 1026 in the main lumen and also navigation sensors 1006 and imaging sensors 1030. Note the navigation sensors 1006 are attached to the catheter 1026 and may include EM sensors ([0097], see also [0044] and [0086]). The catheter 1026 includes an imaging sensor 1030 disposed therein, which may include “stereoscopic or monoscopic endoscopic cameras…” ([0093]). NOTE: Examiner is interpreting the catheter 1026 as including the imaging sensor 1030 in Figure 10 even though it appears to be slidable within the catheter 1026. Nonetheless, MILLER also teaches that the imaging sensor 1030 may “optionally…be included within any type of minimally invasive tool for providing intraoperative images. In various embodiments, imaging sensors 1030 may be slideably disposed through main lumen 1004, slideably disposed within a secondary lumen offset from main lumen 1004, fixed within the main lumen or the secondary lumen, integrated into a wall of the elongate device 1002, fixed to the instruments 1026, or disposed external to elongate device 1002.” ([0093]).
a workstation operably coupled to the EWC and the catheter, the workstation including a memory and a processor, the memory storing instructions. (See control system 122 and manipulator assembly 120 in Figure 1 and control system 812 and manipulator assembly 802 in Figure 8). The memory when executed by the processor can cause the processor to:
determine a location and an orientation of the distal end of the EWC. “Sensor system 808 can include one or more subsystems for receiving information about the instruments of manipulator assembly 802. The sensor system 808 may include sensors 106, 108, for example. Such subsystems may include a position/location sensor system (e.g., an EM sensor system); a shape sensor system for determining the position, orientation, speed, velocity, pose, and/or shape of a distal end and/or of one or more segments along a flexible body that may make up medical instrument 804;….” ([0086]).
receive real-time images of the patient’s anatomy from the camera of the catheter. Following the portion of [0086] above “…and/or a visualization system for capturing images from the distal end of medical instrument 804.” (See also [0093]: “As with imaging sensor 230, imaging sensors 1030 may include a distal portion at or near the distal end portion 1018 of the flexible body 1016 for capturing images and a cable coupled to the imaging sensors 1030 for transmitting the captured image data. The captured image data is processed by an imaging system, such as visualization system 131, for display and/or for use in a tracking system….”).
With respect to the re-centering and tension of the distal end, MILLER teaches that “[t]he various imaging sensors 1030, navigation sensors 1006, and imaging analyses described herein may be used in isolation or in combination to assist with manually or automatically navigating the elongate device 1002 through the pylorus and into the pyloric channel using the computer-assisted teleoperated medical system 800, as feedback to align and navigate the elongate device 1002 with the pyloric sphincter and pyloric channel. For example, via the computer-assisted teleoperated medical system 800, the pose of the distal end portion 1018 relative to the pylorus may be adjusted manually or automatically based on the feedback from the sensors and imaging analyses.” The process may include imaging analysis. “In some embodiments, navigation through the pylorus is further enhanced by using image analyses. The imaging sensors 1030 in conjunction with the visualization system 131 and display system 110 are used to track alignment of the elongate device 1002 relative to the pylorus and or ligament of treitz and provide navigational guidance. Feedback such as visual, audible, and/or vibration may be provided to the user for navigational guidance.” ([0100]).
identify a centerpoint of a lumen within the received real-time images of the patient’s anatomy. “[I]n some embodiments, a re-centering mechanism may be used to manually, robotically assisted with navigational guidance, or automatically center the device 1002 in a lumen….” ([0096]). Moreover, an example of feedback includes “visible arrows or other directional visual analog information may be overlaid on a real time surgical view (e.g., endoscopic view) provided by the imaging sensors 1030 to identify misalignment between the anticipated axis of advancement of distal end portion 1018 and the desired axis of advancement through the pylorus and/or ligament of treitz. The directional visual information can indicate proposed corrective action to a user to correct the misalignment between the distal end portion 1018 and the pylorus and/or ligament of treitz and thereby help enhance navigational alignment (e.g., by maintaining centerline alignment to prevent or minimize undesirable contact of the elongate device 1002 with the lumen sidewall distal of the pylorus).” ([0100]).” NOTE: In order to propose corrective actions to maintain “centerline alignment” the centerpoint of a lumen within the real-time images must be identified.
determine if a center of the catheter is aligned with the identified centerpoint of the lumen. “Moreover, an example of feedback includes “visible arrows or other directional visual analog information may be overlaid on a real time surgical view (e.g., endoscopic view) provided by the imaging sensors 1030 to identify misalignment between the anticipated axis of advancement of distal end portion 1018 and the desired axis of advancement through the pylorus and/or ligament of treitz. The directional visual information can indicate proposed corrective action to a user to correct the misalignment between the distal end portion 1018 and the pylorus and/or ligament of treitz and thereby help enhance navigational alignment (e.g., by maintaining centerline alignment to prevent or minimize undesirable contact of the elongate device 1002 with the lumen sidewall distal of the pylorus).” ([0100]; see also [0106]: “Optionally, in some embodiments, the imaging sensors 1030 may sense a misalignment between a desired orientation of advancement and the device 1002 (such as, for example, an approximate center of the lumen).”) NOTE: Although the above may be in the context of proposing manual corrections, MILLER also teaches that these corrections can be performed automatically or at least robotically assist the user. (see, e.g., [0096]).
articulate, if the catheter is misaligned with the identified centerpoint of the lumen, the distal end of the EWC using the drive mechanism to align the distal end of the EWC with the identified centerpoint of the lumen. “The navigation sensors 1006 and the imaging sensors 1030 may be used to…automatically re-center the elongate device 1002 within the lumens, for example,…based on misalignment with a desired orientation of advancement (such as an approximate center of the lumen). Such re-centering optionally may be applied to the distal end portion 1018….” ([0107]). The re-centering may be performed by “a re-centering mechanism…based on cable, linkage, or other steering control mechanism of portions of the flexible body 1016.” ([0112]). Re-centering may also be performed by an “expandable member 1020” ([0111]).
It is not clear that MILLER explicitly teaches that the processor is configured to determine if the distal end of the EWC is located within an airway having a diameter that approximates an outer diameter of the catheter; and instruct, if the distal end of the EWC is located within an airway having a diameter that approximates the outer diameter of the catheter, the drive mechanism to reduce tension on the distal end of the EWC to permit the distal end of the EWC to deflect when contacting walls of the lumen. However, MILLER does teach the diameter of the patient’s anatomy may be determined using images. “The model may then be built including diameters of the of the anatomy by using…data from imaging sensor 230 where diameter can be determined using image-based methods.” ([0055]). MILLER also teaches that the end of the elongated device may have “selective compliance” based on different variables. “For example, the device tip may be programmed to become more or less compliant (e.g. automatically varying tension in pull wires used to articulate the device in bending, automatically activating stiffening mechanisms, etc.) based on detected tissue contact. In some examples, such selective compliance may depend on time, phase of the procedure, inputs from the user, and other variables.” ([0096]).
In the same field of endeavor, WAI AU teaches a flexible medical instrument that may include “computer-assisted control of instrument characteristics such as the orientation or rigidity of a portion of the instrument.” (Abstract). WAI AU notes that “[d]uring the insertion process, catheter-tissue interactions may occur and may prevent or resist the advancement of the catheter in an airway.” To address this issue, WAI AU teaches enabling the user to “reduce the level of rigidity or stiffness of at least distal portion 114.” ([0021]). “[D]istal portion 114 may be made highly compliant during execution of block 240, which allows distal portion 114 to relax and conform to the shape of instrument 110 to the shape of the airway in which instrument 110 resides. When portion 114 relaxes, friction of instrument 110 against the walls of the airways may drop dramatically… Relaxing the tip in block 240 will generally allow an instrument such as a catheter to move forward along the lumen direction when insertion pressure is applied.” ([0021]). Notably, when the stiffness of the distal portion is relaxed (i.e., the working channel’s tension is reduced), the distal portion will necessarily be more easily deflected by the wall of the airway the distal portion is within.
Accordingly, WAI AU teaches reducing tension of the distal end of an elongated instrument when catheter-tissue interactions occur (i.e., friction between the tissue and the distal end), thereby permitting the elongated instrument to deflect when contacting walls of the lumen.
In the same field of endeavor, STOY teaches that “[t]o navigate tight, tortuous paths and perform complex motions (e.g., at a surgical work site), it may therefore be desirable to provide a surgical device that is sufficiently flexible to follow a variously curved path in a flexible state, while also providing sufficient rigidity in a stiffened state.” ([0007]). To this end, STOY teaches
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“[a] surgical device comprises a tube including a proximal segment and a distal segment and a plurality of force transmission elements coupled to the tube. The force transmission elements are actuatable to alter the distal segment of the tube between a flexible state and a stiffened state.” (Abstract).
Figures 7 and 8 are shown here to illustrate why the passively flexible tool of STOY is useful for narrower lumen. STOY teaches that the flexible tube 704 shown in Figure 7 can replace the rigid link 804 shown in Figure 8 “to provide an arrangement that can offer increased flexibility to a shaft….” A similar flexible tube is shown in Figure 5B. Here, STOY teaches that “in the flexible state, the tube 304 may passively bend upon external forces acting thereon, such as, for example, when the surgical device 300 encounters a wall of the lumen during its navigation therethrough. In this manner, tissue damage may be minimized by allowing the tube 304, as well as potentially other articulable portions of the device 300, to passively bend upon a portion of the surgical device 300 impacting the lumen.” ([0064]). The flexible tube is made passive (or more flexible) by relaxing cables. ([0064]; see also [0072] regarding cables being controlled by drive motors).
NOTE: Examiner is interpreting “airway having a diameter that approximates the outer diameter of the catheter,” as recited in claim 1, as being taught by an airway having walls that generate significant frictional forces with the distal end of the instrument as taught in WAI AU and STOY. Applicant does not clearly describe what is meant by “approximates.” However, Applicant does disclose that when “the diameter of the lumen approximates the outer dimension of the second catheter the system adjusts the tension applied to the pull wires of the sEWC to permit the sEWC to be deflected when the second catheter abuts or otherwise contacts the walls of the lumen.” ([0040]). Applicant’s system does this for the same reason that is taught in both WAI AU and STOY: “[t]o mitigate potential damage to the walls of the airways.” ([0040] of Applicant’s application). Compare this quoted portion to [0064] of STOY and [0022] of WAI AU.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the MILLER system to determine whether the distal end of the EWC is located within an airway having a diameter that approximates an outer diameter of the catheter, as taught in WAI AU, and, if so, instruct the drive mechanism to reduce tension on the distal end of the EWC to permit the distal end of the EWC to deflect when contacting walls of the lumen, as taught in STOY. One of ordinary skill in the art would have been motivated to increase the flexibility (or reduce the stiffness) of the distal end to reduce the frictional forces with the surrounding lumen walls and avoid damaging the tissue. Moreover, this is suggested by MILLER, which teaches that the elongated device may have “selective compliance” based on “detected tissue contact.” ([0096] of MILLER). There would have been a reasonable expectation of success as WAI AU and STOY teach that the distal end’s rigidity may be reduced to permit the distal segment to become passive and reduce frictional forces with the surrounding lumen walls.
With respect to claim 2, MILLER teaches the memory storing thereon further instructions, which when executed by the processor cause the processor to generate a three-dimensional (3D) representation of a scene distal of the camera of the catheter. MILLER teaches generating an anatomic model or map of the patient anatomy using pre-operative scans that are supplemented with real-time images. “In another embodiment, the initial model is generated from pre-operative scans from imaging data obtained from a CT, PET CT, MRI, DICOM, ultrasound, x-ray, fluoroscopic images or prior small bowel enteroscopy data…[T]he initial model may then be altered, supplemented, or merged with data collected in real time while the elongate body is navigated through anatomy, e.g., position/location data gathered during navigation, endoscopic camera data correlated to positional data….” ([0057]; see also [0073]: “In some embodiments, in process 320 an initial model is made from a generic model of human anatomy or from data such as a CT scan, then the target areas of interest in process 330 are identified during the real time procedure as the anatomy is explored, and then the initial model is updated in a separate process. In some embodiments, the model in process 320 is made while identifying target areas of interest in process 330.”).
To be clear, the model is updated with real-time images from the elongate device’s camera, thereby necessarily showing a scene distal of the camera. “Thus, the initial model may then be altered, supplemented, or merged with data collected in real time while the elongate body is navigated through anatomy, e.g.,…endoscopic camera data correlated to positional data….” ([0057]). This model may be three-dimensional. ([0061]). “At process 340, the target area(s) of interest identified in process 330 are then displayed or rendered on the model of the anatomy generated from process 320 so as to create an updated model… In some embodiments, the model is a 3D model, and so the location and depth of the tissue target can be accurately displayed on the model and highlighted with a specific color, shade, hue, and/or transparency to visibly distinguish target and healthy tissue.” ([0061])
With respect to claim 5, MILLER teaches the memory storing thereon further instructions, which when executed by the processor cause the processor to generate a 3D model of airways of the patient using pre-procedure images of the patient’s anatomy. MILLER primarily concerns the gastrointestinal tract. In that context, MILLER teaches generating an anatomic model or map of the patient anatomy using pre-operative scans that are supplemented with real-time images. “In another embodiment, the initial model is generated from pre-operative scans from imaging data obtained from a CT, PET CT, MRI, DICOM, ultrasound, x-ray, fluoroscopic images or prior small bowel enteroscopy data…[T]he initial model may then be altered, supplemented, or merged with data collected in real time while the elongate body is navigated through anatomy, e.g., position/location data gathered during navigation, endoscopic camera data correlated to positional data….” ([0057]; see also [0073]: “In some embodiments, in process 320 an initial model is made from a generic model of human anatomy or from data such as a CT scan, then the target areas of interest in process 330 are identified during the real time procedure as the anatomy is explored, and then the initial model is updated in a separate process. In some embodiments, the model in process 320 is made while identifying target areas of interest in process 330.”).
MILLER also describes that the anatomy may be airways. “In another example, the medical device can be routed through a patient trachea into branches of patient airways to model patient lungs for mucosal resurfacing or ablation for treatment of lung conditions. Individual airway branches can be marked visually during navigation and treatment overlaps can be determined during a procedure such as for treatments for chronic obstructive bronchitis or asthma (for example, using RF ablation, cryospray, plasma energy, ultrasonic waves, microwave, electroporation, etc.).” ([0084]).
With respect to claim 11, MILLER teaches a method for navigating a surgical device to an area of interest. “Aspects of the present disclosure are directed to systems and methods…to accessing and providing therapy to intra-body target tissue during a medical or surgical procedure.” ([0002]). While the illustrated embodiment is directed toward procedures within the gastrointenstinal tract, MILLER clearly teaches that the systems and methods may be directed toward endobronchial-type procedures. “In another example, the medical device can be routed through a patient trachea into branches of patient airways to model patient lungs for mucosal resurfacing or ablation for treatment of lung conditions. Individual airway branches can be marked visually during navigation and treatment overlaps can be determined during a procedure such as for treatments for chronic obstructive bronchitis or asthma (for example, using RF ablation, cryospray, plasma energy, ultrasonic waves, microwave, electroporation, etc.).” ([0084]). The method includes:
determining a pose of a distal end of an extended working channel (EWC). “Via the computer-assisted teleoperated medical system 800, the pose of the distal end portion 1018 relative to the pylorus may be adjusted manually, automatically, or under robotically assisted control to reduce the sensed forces and thus reduce friction on the device 1002, for example, as the device 1002 navigates the pylorus and into the duodenum. Further, in some embodiments, as described in more detail below, the pose of the distal end portion 1018 may be adjusted manually or automatically to reduce the sensed forces, for example, as the device 1002 travels through duodenum.” ([0096]; see also [0086]). See also discussion above with respect to claim 1.
receiving real-time images of a patient’s anatomy from a camera coupled to a catheter, the catheter received within a portion of the EWC. As discussed above with respect to claim 1, the catheter is slidable within a working channel and may include a slideably disposed imaging sensor within the catheter or may include an imaging sensor integrated with the catheter. (see, e.g., [0093]). Furthermore, “[t]he imaging sensors 1030 in conjunction with the visualization system 131 and display system 110 are used to track alignment of the elongate device 1002 relative to [patient anatomy] and provide navigational guidance…For example, visible arrows or other directional visual analog information may be overlaid on a real time surgical view (e.g., endoscopic view) provided by the imaging sensors 1030 to identify misalignment between the anticipated axis of advancement of distal end portion 1018 and the desired axis of advancement through the pylorus and/or ligament of treitz.” ([0100]; see also [0086] and [0093] as discussed above with respect to claim 1).
identifying a centerpoint of a lumen within the received real-time images of the patient’s anatomy. “[I]n some embodiments, a re-centering mechanism may be used to manually, robotically assisted with navigational guidance, or automatically center the device 1002 in a lumen….” ([0096]). Moreover, an example of feedback includes “visible arrows or other directional visual analog information may be overlaid on a real time surgical view (e.g., endoscopic view) provided by the imaging sensors 1030 to identify misalignment between the anticipated axis of advancement of distal end portion 1018 and the desired axis of advancement through the pylorus and/or ligament of treitz. The directional visual information can indicate proposed corrective action to a user to correct the misalignment between the distal end portion 1018 and the pylorus and/or ligament of treitz and thereby help enhance navigational alignment (e.g., by maintaining centerline alignment to prevent or minimize undesirable contact of the elongate device 1002 with the lumen sidewall distal of the pylorus).” ([0100]).” NOTE: In order to propose corrective actions to maintain “centerline alignment” the centerpoint of a lumen within the real-time images must be identified.
determining if a center of the catheter is aligned with the identified centerpoint of the lumen. “Moreover, an example of feedback includes “visible arrows or other directional visual analog information may be overlaid on a real time surgical view (e.g., endoscopic view) provided by the imaging sensors 1030 to identify misalignment between the anticipated axis of advancement of distal end portion 1018 and the desired axis of advancement through the pylorus and/or ligament of treitz. The directional visual information can indicate proposed corrective action to a user to correct the misalignment between the distal end portion 1018 and the pylorus and/or ligament of treitz and thereby help enhance navigational alignment (e.g., by maintaining centerline alignment to prevent or minimize undesirable contact of the elongate device 1002 with the lumen sidewall distal of the pylorus).” ([0100]; see also [0106]: “Optionally, in some embodiments, the imaging sensors 1030 may sense a misalignment between a desired orientation of advancement and the device 1002 (such as, for example, an approximate center of the lumen).”) NOTE: Although the above may be in the context of proposing manual corrections, MILLER also teaches that these corrections can be performed automatically or at least robotically assist the user. (see, e.g., [0096]).
articulating, if the catheter is misaligned with the identified centerpoint of the lumen, the distal end of the EWC using a drive mechanism to align the distal end of the EWC with the identified centerpoint of the lumen, wherein the drive mechanism is operably coupled to the EWC. “The navigation sensors 1006 and the imaging sensors 1030 may be used to…automatically re-center the elongate device 1002 within the lumens, for example,…based on misalignment with a desired orientation of advancement (such as an approximate center of the lumen). Such re-centering optionally may be applied to the distal end portion 1018….” ([0107]). The re-centering may be performed by “a re-centering mechanism…based on cable, linkage, or other steering control mechanism of portions of the flexible body 1016.” ([0112]). Re-centering may also be performed by an “expandable member 1020” ([0111]). With respect to the claimed drive mechanism, “[t]he elongate device 102 optionally may be coupled to or in communication with a variety of systems, including a kinematic arm manipulator assembly 120….” ([0042]).
It is not clear that MILLER explicitly teaches determining if the distal end of the EWC is located within an airway having a diameter that approximates an outer diameter of the catheter; and instructing, if the distal end of the EWC is located within an airway having a diameter that approximates the outer diameter of the catheter, the drive mechanism to reduce tension on the distal end of the EWC to permit the distal end of the EWC to deflect when contacting walls of the lumen. However, MILLER does teach the diameter of the patient’s anatomy may be determined using images. “The model may then be built including diameters of the of the anatomy by using…data from imaging sensor 230 where diameter can be determined using image-based methods.” ([0055]). MILLER also teaches that the end of the elongated device may have “selective compliance” based on different variables. “For example, the device tip may be programmed to become more or less compliant (e.g. automatically varying tension in pull wires used to articulate the device in bending, automatically activating stiffening mechanisms, etc.) based on detected tissue contact. In some examples, such selective compliance may depend on time, phase of the procedure, inputs from the user, and other variables.” ([0096]).
In the same field of endeavor, WAI AU teaches a flexible medical instrument that may include “computer-assisted control of instrument characteristics such as the orientation or rigidity of a portion of the instrument.” (Abstract). WAI AU notes that “[d]uring the insertion process, catheter-tissue interactions may occur and may prevent or resist the advancement of the catheter in an airway.” To address this issue, WAI AU teaches enabling the user to “reduce the level of rigidity or stiffness of at least distal portion 114.” ([0021]). “[D]istal portion 114 may be made highly compliant during execution of block 240, which allows distal portion 114 to relax and conform to the shape of instrument 110 to the shape of the airway in which instrument 110 resides. When portion 114 relaxes, friction of instrument 110 against the walls of the airways may drop dramatically… Relaxing the tip in block 240 will generally allow an instrument such as a catheter to move forward along the lumen direction when insertion pressure is applied.” ([0021]). Notably, when the stiffness of the distal portion is relaxed (i.e., the working channel’s tension is reduced), the distal portion will necessarily be more easily deflected by the wall of the airway the distal portion is within.
Accordingly, WAI AU teaches reducing tension of the distal end of an elongated instrument when catheter-tissue interactions occur (i.e., friction between the tissue and the distal end), thereby permitting the elongated instrument to deflect when contacting walls of the lumen.
In the same field of endeavor, STOY teaches that “[t]o navigate tight, tortuous paths and perform complex motions (e.g., at a surgical work site), it may therefore be desirable to provide a surgical device that is sufficiently flexible to follow a variously curved path in a flexible state, while also providing sufficient rigidity in a stiffened state.” ([0007]). To this end, STOY teaches “[a] surgical device comprises a tube including a proximal segment and a distal segment and a plurality of force transmission elements coupled to the tube. The force transmission elements are actuatable to alter the distal segment of the tube between a flexible state and a stiffened state.” (Abstract).
Figures 7 and 8 are shown here to illustrate why the passively flexible tool of STOY is useful for narrower lumen. STOY teaches that the flexible tube 704 shown in Figure 7 can replace the rigid link 804 shown in Figure 8 “to provide an arrangement that can offer increased flexibility to a shaft….” A similar flexible tube is shown in Figure 5B. Here, STOY teaches that “in the flexible state, the tube 304 may passively bend upon external forces acting thereon, such as, for example, when the surgical device 300 encounters a wall of the lumen during its navigation therethrough. In this manner, tissue damage may be minimized by allowing the tube 304, as well as potentially other articulable portions of the device 300, to passively bend upon a portion of the surgical device 300 impacting the lumen.” ([0064]). The flexible tube is made passive (or more flexible) by relaxing cables. ([0064]; see also [0072] regarding cables being controlled by drive motors).
NOTE: Examiner is interpreting “airway having a diameter that approximates the outer diameter of the catheter,” as recited in claim 11, as being taught by an airway having walls that generate significant frictional forces with the distal end of the instrument as taught in WAI AU and STOY. Applicant does not clearly describe what is meant by “approximates.” However, Applicant does disclose that when “the diameter of the lumen approximates the outer dimension of the second catheter the system adjusts the tension applied to the pull wires of the sEWC to permit the sEWC to be deflected when the second catheter abuts or otherwise contacts the walls of the lumen.” ([0040]). Applicant’s system does this for the same reason that is taught in both WAI AU and STOY: “[t]o mitigate potential damage to the walls of the airways.” ([0040] of Applicant’s application). Compare this quoted portion to [0064] of STOY and [0022] of WAI AU.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the MILLER system to determine whether the distal end of the EWC is located within an airway having a diameter that approximates an outer diameter of the catheter, as taught in WAI AU, and, if so, instruct the drive mechanism to reduce tension on the distal end of the EWC to permit the distal end of the EWC to deflect when contacting walls of the lumen, as taught in STOY. One of ordinary skill in the art would have been motivated to increase the flexibility (or reduce the stiffness) of the distal end to reduce the frictional forces with the surrounding lumen walls and avoid damaging the tissue. Moreover, this is suggested by MILLER, which teaches that the elongated device may have “selective compliance” based on “detected tissue contact.” ([0096] of MILLER). There would have been a reasonable expectation of success as WAI AU and STOY teach that the distal end’s rigidity may be reduced to permit the distal segment to become passive and reduce frictional forces with the surrounding lumen walls.
With respect to claim 12, MILLER teaches generating a three-dimensional (3D) representation of a scene distal of the camera of the catheter. MILLER teaches generating an anatomic model or map of the patient anatomy using pre-operative scans that are supplemented with real-time images. “In another embodiment, the initial model is generated from pre-operative scans from imaging data obtained from a CT, PET CT, MRI, DICOM, ultrasound, x-ray, fluoroscopic images or prior small bowel enteroscopy data…[T]he initial model may then be altered, supplemented, or merged with data collected in real time while the elongate body is navigated through anatomy, e.g., position/location data gathered during navigation, endoscopic camera data correlated to positional data….” ([0057]; see also [0073]: “In some embodiments, in process 320 an initial model is made from a generic model of human anatomy or from data such as a CT scan, then the target areas of interest in process 330 are identified during the real time procedure as the anatomy is explored, and then the initial model is updated in a separate process. In some embodiments, the model in process 320 is made while identifying target areas of interest in process 330.”).
To be clear, the model is updated with real-time images from the elongate device’s camera, thereby necessarily showing a scene distal of the camera. “Thus, the initial model may then be altered, supplemented, or merged with data collected in real time while the elongate body is navigated through anatomy, e.g.,…endoscopic camera data correlated to positional data….” ([0057]). This model may be three-dimensional. ([0061]). “At process 340, the target area(s) of interest identified in process 330 are then displayed or rendered on the model of the anatomy generated from process 320 so as to create an updated model… In some embodiments, the model is a 3D model, and so the location and depth of the tissue target can be accurately displayed on the model and highlighted with a specific color, shade, hue, and/or transparency to visibly distinguish target and healthy tissue.” ([0061]).
With respect to claim 16, MILLER teaches a method for navigating a surgical device to an area of interest. “Aspects of the present disclosure are directed to systems and methods…to accessing and providing therapy to intra-body target tissue during a medical or surgical procedure.” ([0002]). While the illustrated embodiment is directed toward procedures within the gastrointenstinal tract, MILLER clearly teaches that the systems and methods may be directed toward endobronchial-type procedures. “In another example, the medical device can be routed through a patient trachea into branches of patient airways to model patient lungs for mucosal resurfacing or ablation for treatment of lung conditions. Individual airway branches can be marked visually during navigation and treatment overlaps can be determined during a procedure such as for treatments for chronic obstructive bronchitis or asthma (for example, using RF ablation, cryospray, plasma energy, ultrasonic waves, microwave, electroporation, etc.).” ([0084]). The method includes:
determining a pose of a distal end of an extended working channel (EWC) using an inertial measurement unit coupled to the EWC. “[T]he one or more navigation sensors 1006 may also include one or more gravity field sensors, such as inertial measurement units (IMU) or accelerometers or inclinometers to help properly align the distal tip of the elongate device 1002 in order to traverse the pylorus.” ([0099]; see also [0106]). “Localization sensors can include sensors (e.g., a single position sensor 106, a plurality of position sensors distributed along the length of the elongate device 102, a shape sensor 108, and/or an imaging sensor) coupled to the tracking system 130 for receiving and processing sensor data and information for determining the position, orientation, speed, velocity, pose, and/or shape of distal end 118 and/or of one or more lengths along the flexible body 116.” ([0043]). “Via the computer-assisted teleoperated medical system 800, the pose of the distal end portion 1018 relative to the pylorus may be adjusted manually, automatically, or under robotically assisted control to reduce the sensed forces and thus reduce friction on the device 1002, for example, as the device 1002 navigates the pylorus and into the duodenum.” ([0096]; see also [0086]). See also discussion above with respect to claim 1.
receiving real-time images of a patient’s anatomy from a camera coupled to a catheter, wherein the catheter is received within a portion of the EWC. As discussed above with respect to claim 1, the catheter is slidable within a working channel and may include a slideably disposed imaging sensor within the catheter or may include an imaging sensor integrated with the catheter. (see, e.g., [0093]). Furthermore, “[t]he imaging sensors 1030 in conjunction with the visualization system 131 and display system 110 are used to track alignment of the elongate device 1002 relative to [patient anatomy] and provide navigational guidance…For example, visible arrows or other directional visual analog information may be overlaid on a real time surgical view (e.g., endoscopic view) provided by the imaging sensors 1030 to identify misalignment between the anticipated axis of advancement of distal end portion 1018 and the desired axis of advancement through the pylorus and/or ligament of treitz.” ([0100]; see also [0086] and [0093] as discussed above with respect to claim 1).
articulating the distal end of the EWC, using a drive mechanism coupled to the EWC, to align a distal portion of the catheter with a lumen of a bifurcation identified within the received real-time images. “The navigation sensors 1006 and the imaging sensors 1030 may be used to…automatically re-center the elongate device 1002 within the lumens, for example,…based on misalignment with a desired orientation of advancement (such as an approximate center of the lumen). Such re-centering optionally may be applied to the distal end portion 1018….” ([0107]). The re-centering may be performed by “a re-centering mechanism…based on cable, linkage, or other steering control mechanism of portions of the flexible body 1016.” ([0112]). Re-centering may also be performed by an “expandable member 1020” ([0111]). With respect to the claimed drive mechanism, “[t]he elongate device 102 optionally may be coupled to or in communication with a variety of systems, including a kinematic arm manipulator assembly 120….” ([0042]).
It is not clear that MILLER explicitly teaches instructing the drive mechanism to reduce tension on the distal end of the EWC if a determined outer dimension of the lumen approximates an outer dimension of the catheter to permit the distal end of the EWC to deflect when contacting walls of the lumen. However, MILLER does teach the diameter of the patient’s anatomy may be determined using images. “The model may then be built including diameters of the of the anatomy by using…data from imaging sensor 230 where diameter can be determined using image-based methods.” ([0055]). MILLER also teaches that the end of the elongated device may have “selective compliance” based on different variables. “For example, the device tip may be programmed to become more or less compliant (e.g. automatically varying tension in pull wires used to articulate the device in bending, automatically activating stiffening mechanisms, etc.) based on detected tissue contact. In some examples, such selective compliance may depend on time, phase of the procedure, inputs from the user, and other variables.” ([0096]).
In the same field of endeavor, WAI AU teaches a flexible medical instrument that may include “computer-assisted control of instrument characteristics such as the orientation or rigidity of a portion of the instrument.” (Abstract). WAI AU notes that “[d]uring the insertion process, catheter-tissue interactions may occur and may prevent or resist the advancement of the catheter in an airway.” To address this issue, WAI AU teaches enabling the user to “reduce the level of rigidity or stiffness of at least distal portion 114.” ([0021]). “[D]istal portion 114 may be made highly compliant during execution of block 240, which allows distal portion 114 to relax and conform to the shape of instrument 110 to the shape of the airway in which instrument 110 resides. When portion 114 relaxes, friction of instrument 110 against the walls of the airways may drop dramatically… Relaxing the tip in block 240 will generally allow an instrument such as a catheter to move forward along the lumen direction when insertion pressure is applied.” ([0021]). Notably, when the stiffness of the distal portion is relaxed (i.e., the working channel’s tension is reduced), the distal portion will necessarily be more easily deflected by the wall of the airway the distal portion is within.
Accordingly, WAI AU teaches reducing tension of the distal end of an elongated instrument when catheter-tissue interactions occur (i.e., friction between the tissue and the distal end), thereby permitting the elongated instrument to deflect when contacting walls of the lumen.
In the same field of endeavor, STOY teaches that “[t]o navigate tight, tortuous paths and perform complex motions (e.g., at a surgical work site), it may therefore be desirable to provide a surgical device that is sufficiently flexible to follow a variously curved path in a flexible state, while also providing sufficient rigidity in a stiffened state.” ([0007]). To this end, STOY teaches “[a] surgical device comprises a tube including a proximal segment and a distal segment and a plurality of force transmission elements coupled to the tube. The force transmission elements are actuatable to alter the distal segment of the tube between a flexible state and a stiffened state.” (Abstract).
Figures 7 and 8 are shown here to illustrate why the passively flexible tool of STOY is useful for narrower lumen. STOY teaches that the flexible tube 704 shown in Figure 7 can replace the rigid link 804 shown in Figure 8 “to provide an arrangement that can offer increased flexibility to a shaft….” A similar flexible tube is shown in Figure 5B. Here, STOY teaches that “in the flexible state, the tube 304 may passively bend upon external forces acting thereon, such as, for example, when the surgical device 300 encounters a wall of the lumen during its navigation therethrough. In this manner, tissue damage may be minimized by allowing the tube 304, as well as potentially other articulable portions of the device 300, to passively bend upon a portion of the surgical device 300 impacting the lumen.” ([0064]). The flexible tube is made passive (or more flexible) by relaxing cables. ([0064]; see also [0072] regarding cables being controlled by drive motors).
NOTE: Examiner is interpreting “determined outer dimension of the lumen approximates an outer dimension of the catheter,” as recited in claim 16, as being taught by an airway having walls that generate significant frictional forces with the distal end of the instrument as taught in WAI AU and STOY. Applicant does not clearly describe what is meant by “approximates.” However, Applicant does disclose that when “the diameter of the lumen approximates the outer dimension of the second catheter the system adjusts the tension applied to the pull wires of the sEWC to permit the sEWC to be deflected when the second catheter abuts or otherwise contacts the walls of the lumen.” ([0040]). Applicant’s system does this for the same reason that is taught in both WAI AU and STOY: “[t]o mitigate potential damage to the walls of the airways.” ([0040] of Applicant’s application). Compare the quoted portion above to [0064] of STOY and [0022] of WAI AU. Moreover, the phrase “determined outer dimension,” as recited, does not require that the outer dimension is a value that is determined using a specific method, such as image analysis. Nonetheless, MILLER does teach that the diameters may be determined through image analysis. (see, e.g., [0055] of MILLER) and that “selective compliance” may be based on “other variables.” ([0096]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the MILLER system to instruct the drive mechanism to reduce tension on the distal end of the EWC, as taught in WAI AU and STOY, if a determined outer dimension of the lumen approximates an outer dimension of the catheter to permit the distal end of the EWC to deflect when contacting walls of the lumen, as taught in WAI AU and STOY. One of ordinary skill in the art would have been motivated to increase the flexibility (or reduce the stiffness) of the distal end to reduce the frictional forces with the surrounding lumen walls and avoid damaging the tissue. Moreover, this is suggested by MILLER, which teaches that the elongated device may have “selective compliance” based on “detected tissue contact.” ([0096] of MILLER). There would have been a reasonable expectation of success as WAI AU and STOY teach that the distal end’s rigidity may be reduced to permit the distal segment to become passive and reduce frictional forces with the surrounding lumen walls.
With respect to claim 17 (depending from claim 16), MILLER teaches, as discussed above with respect to claim 12, generating a three-dimensional (3D) representation of a scene distal of the camera of the catheter. MILLER teaches generating an anatomic model or map of the patient anatomy using pre-operative scans that are supplemented with real-time images. “In another embodiment, the initial model is generated from pre-operative scans from imaging data obtained from a CT, PET CT, MRI, DICOM, ultrasound, x-ray, fluoroscopic images or prior small bowel enteroscopy data…[T]he initial model may then be altered, supplemented, or merged with data collected in real time while the elongate body is navigated through anatomy, e.g., position/location data gathered during navigation, endoscopic camera data correlated to positional data….” ([0057]; see also [0073]: “In some embodiments, in process 320 an initial model is made from a generic model of human anatomy or from data such as a CT scan, then the target areas of interest in process 330 are identified during the real time procedure as the anatomy is explored, and then the initial model is updated in a separate process. In some embodiments, the model in process 320 is made while identifying target areas of interest in process 330.”).
To be clear, the model is updated with real-time images from the elongate device’s camera, thereby necessarily showing a scene distal of the camera. “Thus, the initial model may then be altered, supplemented, or merged with data collected in real time while the elongate body is navigated through anatomy, e.g.,…endoscopic camera data correlated to positional data….” ([0057]). This model may be three-dimensional. ([0061]). “At process 340, the target area(s) of interest identified in process 330 are then displayed or rendered on the model of the anatomy generated from process 320 so as to create an updated model… In some embodiments, the model is a 3D model, and so the location and depth of the tissue target can be accurately displayed on the model and highlighted with a specific color, shade, hue, and/or transparency to visibly distinguish target and healthy tissue.” ([0061]).
Claims 3, 4, 6-8, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publ. No. 2023/0071306 A1 (hereinafter “MILLER”) and U.S. Patent Application Publ. No. 2017/0281288 A1 (hereinafter “WAI AU”) and U.S. Patent Application Publ. No. 2015/0245826 A1 (hereinafter “STOY”) as applied to claims 1, 2, 12, and 17 above, and further in view of U.S. Patent Application Publ. No. 2018/0368920 A1 (hereinafter “UMMALANENI”).
With respect to claim 3, MILLER does not explicitly teach a memory that stores thereon further instructions, which when executed by the processor cause the processor to generate the 3D representation of the scene using pixel-wise depth estimation. However, MILLER teaches that the model used during surgery may be “a 3D model…[in which] the location and depth of the tissue target can be accurately displayed on the model and highlighted with a specific color, shade, hue, and/or transparency to visibly distinguish target and healthy tissue.” ([0061]). Moreover, the MILLER system is clearly capable of generating a depth map. “After an initial depth map is generated, radial ultrasound or other sensors may be used at the time of treatment so that the depth map can be used to localize treatment.” ([0131]).
In the same field of endeavor, UMMALANENI teaches “systems and techniques for navigation-assisted medical devices...[which include] correlating features of depth information generated based on captured images of an anatomical luminal network with virtual features of depth information generated based on virtual images of a virtual representation of the anatomical luminal network in order to automatically determine aspects of a roll of a medical device within the luminal network.” (Abstract). UMMALANENI addresses problems and drawbacks for navigating the distal end of an endoscope through airways. (see, e.g., [0005]-[0007]). To address these issues, “[t]he disclosed techniques can generate a 3D model of a virtual luminal network representing the patient's anatomical luminal network and can determine a number of locations within the virtual luminal network at which to position a virtual camera.” ([0008]).
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A portion of Figure 21 of UMMALANENI is shown here and “depicts a flowchart of an example intra-operative process for generating depth information based on captured endoscopic images….” ([0052]). The process includes using an endoscopic image from the distal end and generating a depth map based on the endoscopic image. (see, e.g., [0185] and [0186]). “Feature extractor 450 can calculate, for each pixel of the imaging data, a depth value representing an estimated distance between the imaging device and a tissue surface within the anatomical luminal network represented that is corresponding to the pixel.” ([0186]). These features can be used to determine “an estimated pose of the distal end of the instrument within the anatomical luminal network based on the virtual location associated with the virtual feature….” ([0192]). “The pose can include the position of the instrument (e.g., insertion depth within a segment of an airway or other luminal network portion), the roll, pitch, and/or yaw of the instrument, or other degrees of freedom.” ([0192]).
UMMALANENI teaches that, with the distal end pose known, an endoscopic view within the patient can be shown. “The 3D images provide an “endo view” (i.e., endoscopic view), which is a computer 3D model illustrating the anatomy of a patient. The “endo view” provides a virtual environment of the patient's interior and an expected location of an endoscope 115 inside the patient. A user 205 compares the “endo view” model to actual images captured by a camera to help mentally orient and confirm that the endoscope 115 is in the correct—or approximately correct—location within the patient. The “endo view” provides information about anatomical structures, e.g., the shape of airways, circulatory vessels, or an intestine or colon of the patient, around the distal end of the endoscope 115.” ([0139]). “The navigation controller 460 can cause display of side-by-side views of a slice of the 3D model at the estimated position and of the real-time images received from the scope imaging data repository 480 in some embodiments in order to facilitate user-guided navigation.” ([0174]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the MILLER system to generate the 3D representation of the scene using pixel-wise depth estimation, as taught in UMMALANENI. One of ordinary skill in the art would have been motivated to use the depth maps, along with other data, to more accurately determine the pose and location of the distal end of the instrument, as taught in UMMALANENI, while navigating the airways. There would have been a reasonable expectation of success as UMMALANENI teaches that depth maps can be used for navigating airways.
With respect to claim 4 (depending from claim 3), MILLER does not explicitly teach the memory storing thereon further instructions, which when executed by the processor cause the processor to identify the centerpoint of the lumen using data resulting from the pixel-wise depth estimation.
UMMALANENI teaches that “[d]uring the medical procedure, the distal end of an endoscope can be provided with an imaging device, and the disclosed navigation techniques can generate a depth map based on image data received from the imaging devices. The disclosed techniques can derive features from the generated depth map, calculate correspondence between the extracted features with the stored features extracted from one of the virtual depth maps, and then use the associated virtual camera location as the initial position of the distal end of the instrument.” ([0008]).
More specifically, the techniques in UMMALANENI can be used to “refine registration” between the pre-operative and intra-operative images. ([0008]; see also [0012]). UMMALANENI determines depth criteria that help distinguish different bronchus. In order to identify a centerpoint of a lumen, it would be necessary to identify or distinguish different bronchus. NOTE: The phrase “using data resulting from the pixel-wise depth estimation” is being interpreted as using pixel-wise depth estimation data to directly or indirectly identify the centerpoint. (MPEP 2111, “broadest reasonable interpretation”).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the MILLER system to identify the centerpoint of the lumen using data resulting from the pixel-wise depth estimation, as taught in UMMALANENI. One of ordinary skill in the art would have been motivated to use the pixel-wise depth estimation data to refine registration of the distal end location and/or identify different bronchus, as taught in UMMALANENI, which would necessarily at least partially determine the location of the centerpoint of a lumen. There would have been a reasonable expectation of success as UMMALANENI teaches that depth maps can be used for navigating airways.
With respect to claim 6 (depending from claim 5), MILLER does not explicitly teach the memory storing thereon further instructions, which when executed by the processor cause the processor to generate a pathway through the airways of the patient to target tissue identified in the generated 3D model.
With respect to claim 7 (depending from claim 6), MILLER does not explicitly teach the memory storing thereon further instructions, which when executed by the processor cause the processor to identify a bifurcation within the received real-time images of the patient’s anatomy.
With respect to claim 8 (depending from claim 7), MILLER does not explicitly teach the memory storing thereon further instructions, which when executed by the processor cause the processor to articulate the distal end of the EWC using the drive mechanism to align the distal end of the EWC with a lumen of the bifurcation associated with the pathway to the target tissue.
With respect to claims 13 (depending from claim 12) and claim 18 (depending from claim 17), as discussed above with respect to claims 3 and 4 and UMMALANENI, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the MILLER system to generate the 3D representation of the scene using pixel-wise depth estimation, as taught in UMMALANENI. One of ordinary skill in the art would have been motivated to use the depth maps, along with other data, to more accurately determine the pose and location of the distal end of the instrument, as taught in UMMALANENI, while navigating the airways. There would have been a reasonable expectation of success as UMMALANENI teaches that depth maps can be used for navigating airways.
Claims 9, 10, 14, 15, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publ. No. 2023/0071306 A1 (hereinafter “MILLER”) and U.S. Patent Application Publ. No. 2017/0281288 A1 (hereinafter “WAI AU”) and U.S. Patent Application Publ. No. 2015/0245826 A1 (hereinafter “STOY”) as applied to claims 1, 11, and 16 above and further in view of U.S. Patent Application Publ. No. 2022/0361968 A1 (hereinafter “NOONAN”).
With respect to claim 9, none of the cited art explicitly teach having a memory storing thereon further instructions, which when executed by the processor cause the processor to determine if a position of the distal end of the EWC within the patient’s airways has changed within a predetermined time period.
NOONAN teaches a “co-manipulation robotic system” that operates in multiple modes “to enhance usability and safety….” (Abstract). One of the modes is a “passive mode” in which the controller may be programmed to “automatically switch” to the passive mode “responsive to determining that movement of the robot arm due to movement at the handle of the surgical instrument is less than a predetermined amount for at least a predetermined dwell time period, wherein the controller may be programmed to cause the robot arm to maintain a static position in the passive mode.” ([0007]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the MILLER system to switch to a passive mode, as taught in NOONAN, after determining that the position of the EWC within the patient has not changed within predetermined period of time. One of ordinary skill in the art would have been motivated to provide this automatic disabling of the drive mechanism to enhance the usability and safety of the MILLER system. There would have been a reasonable expectation of success as NOONAN teaches that surgical systems may be automatically switched to a passive mode.
With respect to claim 10, none of the cited art explicitly teach having a memory storing thereon further instructions, which when executed by the processor cause the processor to disable the drive mechanism if it is determined that the position of the distal end of the EWC has not changed within the predetermined time period.
As discussed above with respect to claim 9, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the MILLER system to switch to a passive mode, as taught in NOONAN, which includes disabling the drive mechanism, after determining that the position of the EWC within the patient has not changed within predetermined period of time. One of ordinary skill in the art would have been motivated to provide this automatic disabling of the drive mechanism to enhance the usability and safety of the MILLER system. There would have been a reasonable expectation of success as NOONAN teaches that surgical systems may be automatically switched to a passive mode.
With respect to claim 14, none of the cited art explicitly teach having a memory storing thereon further instructions, which when executed by the processor cause the processor to determine if a position of the distal end of the EWC within the patient’s airways has changed within a predetermined time period.
As discussed above with respect to claim 9, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the MILLER system to switch to a passive mode, as taught in NOONAN, after determining that the position of the EWC within the patient has not changed within predetermined period of time. One of ordinary skill in the art would have been motivated to provide this automatic disabling of the drive mechanism to enhance the usability and safety of the MILLER system. There would have been a reasonable expectation of success as NOONAN teaches that surgical systems may be automatically switched to a passive mode.
With respect to claim 15, none of the cited art explicitly teach having a memory storing thereon further instructions, which when executed by the processor cause the processor to disable the drive mechanism if it is determined that the position of the distal end of the EWC has not changed within the predetermined time period.
As discussed above with respect to claim 10, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the MILLER system to switch to a passive mode, as taught in NOONAN, which includes disabling the drive mechanism, after determining that the position of the EWC within the patient has not changed within predetermined period of time. One of ordinary skill in the art would have been motivated to provide this automatic disabling of the drive mechanism to enhance the usability and safety of the MILLER system. There would have been a reasonable expectation of success as NOONAN teaches that surgical systems may be automatically switched to a passive mode.
With respect to claim 19, none of the cited art explicitly teach having a memory storing thereon further instructions, which when executed by the processor cause the processor to determine if a position of the distal end of the EWC within the patient’s airways has changed within a predetermined time period.
As discussed above with respect to claim 9, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the MILLER system to switch to a passive mode, as taught in NOONAN, after determining that the position of the EWC within the patient has not changed within predetermined period of time. One of ordinary skill in the art would have been motivated to provide this automatic disabling of the drive mechanism to enhance the usability and safety of the MILLER system. There would have been a reasonable expectation of success as NOONAN teaches that surgical systems may be automatically switched to a passive mode.
With respect to claim 20, none of the cited art explicitly teach having a memory storing thereon further instructions, which when executed by the processor cause the processor to disable the drive mechanism if it is determined that the position of the distal end of the EWC has not changed within the predetermined time period.
As discussed above with respect to claim 10, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the MILLER system to switch to a passive mode, as taught in NOONAN, which includes disabling the drive mechanism, after determining that the position of the EWC within the patient has not changed within predetermined period of time. One of ordinary skill in the art would have been motivated to provide this automatic disabling of the drive mechanism to enhance the usability and safety of the MILLER system. There would have been a reasonable expectation of success as NOONAN teaches that surgical systems may be automatically switched to a passive mode.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2013/0072756 A1 (hereinafter FRASSICA) concerns “push-to-advance” endoscopic designs. ([0073]). FRASSICA also states “there are problems in making present push-in catheters, dilators, and occluders stiff enough for penetration and flexible enough to make the turns without undue risk of trauma to the wall of the passageway when being pushed in….” ([0074]). FRASSICA is concerned with operating the elongated instruments while advancing through passageways of different diameters. ([0374]). To address this issue, FRASSICA teaches automatically decreasing the rigidity of the instruments when detecting passageways with reduced diameters. “Alternatively, threaded camera introducer system 710B may be constructed so that the system can make its own determination as to when, and how, to vary the height and/or rigidity of deformable helical thread 735B…With this construction, when the distal end of the system enters a section of the bodily passageway having a reduced diameter, pressure sensor PS will detect a rise in the pressure of the fluid inflating the deformable helical thread due to entry of the system into the constricted passageway, and the system may then automatically reduce the height and/or rigidity of the thread so as restore the level of pressure in the deformable helical thread.”
US 2019/0298460 A1 (hereinafter AL-JADDA) teaches methods and systems for modulating a bending stiffness profile of bronchoscope having a telescopic arrangement by adjusting the relative positions of the flexible tubular tools (e.g., sheath and scope). (Abstract, [0004], and [0010]). The medical instruments of AL-JADDA have “variable bending stiffness profiles” that “can be useful for navigating through tortuous paths within a patient's anatomy. In some embodiments, the medical instruments with variable bending stiffness profiles can be particularly useful in navigating through the pulmonary airways of a patient. The pulmonary airways can be tortuous paths…Scopes that are sent into the pulmonary airways often want to travel down incorrect pathways and may struggle to enter into the correct pathways.” ([0110]). AL-JADDA describes both manual and robotic implementations. (see, e.g., [0109]). AL-JADDA describes adjusting the bending stiffness of the instrument by adjusting the relative position of the sheath (i.e., working channel) and catheter (i.e., scope (see, e.g., [0129])). “For example, with the particular bending stiffness profile the medical instrument may be inclined to travel down an incorrect pathway and/or may struggle to enter a correct pathway. In such a situation, the physician can modulate or change the bending stiffness profile of the medical instrument by moving the scope relative to the sheath (e.g., inserting the scope further through the sheath such that the scope extends from the sheath, positioning the scope and sheath such that their distal ends are aligned, or retracting the scope within the sheath such that the scope extends beyond the sheath) to modulate the bending stiffness profile.” ([0127]).
Conclusion
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/JASON P GROSS/ Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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