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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/16/2026 has been entered.
Claim Status
Claims 1-20 are currently pending
Claims 4-8 and 10-13 are withdrawn from prosecution.
Claims 1-3, 9, and 14-20 are rejected.
Response to Arguments
Applicant’s request to hold the double patenting rejection in abeyance, until a determination of allowability of the claims, has been noted.
Applicant’s arguments with respect to claims 1, 18 and 19 in Applicant’s responses filed 06/16/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Specifically, newly found prior art Galloway, et al., US 20030000535 A1 teaches mapping a room during image-guided surgery and discloses tracking instruments, mapping the locations of the instrument into an image space and updating the image sets in real-time based on events occurring during the procedure.
Furthermore, newly found prior art, Nagao, US 20220168047 A1 teaches a medical arm system that supports a medical instrument, and adapts a position and posture of the medical instrument with respect to a point on action on the medical instrument. The system also includes a control unit configured to generate or to update mapping information mapping the space surrounding the point of action on a basis of the environment information acquired by the one or more acquisition units and arm state information representing the position and the posture of the medical instrument with respect to the point of action according to a state of the arm unit.
In combination, the prior art teaches the limitations of claims 1, 18 and 19
Therefore, the claims stand rejected.
Withdrawn Rejections
The rejection of claims 1-3, 9, and 14-20 under 35 U.S.C. 112(b) have been withdrawn pursuant of Applicant’s amendments filed 12/15/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 9, and 14-20 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 1, 18 and 19 recites “the one or more first devices being physically separate from a user experience (“UX”) device”. However, the disclosure fails to clearly describe what comprises the UX device. The originally filed specification merely refers to numerals 155 of fig. 1, 265 of fig. 2, and 965 of fig. 9 as the UX device. However, all three diagrams are block diagrams and hence do not provide adequate details of the claimed UX device. [0171] of the originally filed specification states “presenting, using the computing system and using a user experience ("UX") device”, which appears to suggest that the UX device is may be a data presentation structure, however, the statement appears to also indicate that the computing system is the presenting structure. Hence it is unclear what comprises the UX device.
Claims 2-3, 9, and 14-17, and 20 are rejected based on their respective dependencies on claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 9, 14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lang, et al., US 20210137634 A1 in view of Galloway, et al., US 20030000535 A1 and Nagao, US 20220168047 A1.
Regarding claim 1, Lang teaches a method for presenting patient information relating to a patient to a user ([0004] discloses that “devices, systems, methods and techniques for gating and/or moving the display of virtual data by one or more optical head mounted displays using cardiac and/or respiratory gating information are provided”, [0005] indicating that the method includes displaying a virtual image of a patient), comprising:
receiving, using a computing system (“computer system with one or more processors” of [0005]), one or more first layer input data from one or more first devices comprising one or more sensors configured to map a room that includes at least the patient and one or more persons other than the patient, the one or more first layer input data comprising data indicative of at least one of movement, position, or relative distance for at least the one or more persons other than the patient and one or more objects within the room based on sensor data captured external to the patient and the one or more persons other than the patient by the one or more sensos configured to map the room ([0314] Live data, e.g. live data of the patient, the position and/or orientation of a physical instrument, the position and/or orientation of an implant component, the position and/or orientation of one or more OHMD's, can be acquired or registered, for example, using a spatial mapping process. This process creates a three-dimensional mesh describing the surfaces of one or more objects or environmental structures using, for example and without limitation, a depth sensor, laser scanner, structured light sensor, time of flight sensor, infrared sensor, or tracked probe. These devices can generate 3D surface data by collecting, for example, 3D coordinate information or information on the distance from the sensor of one or more surface points on the one or more objects or environmental structures. The 3D surface points can then be connected to 3D surface meshes, resulting in a three-dimensional surface representation of the live data. [0235] also states that “3D scanning can be used for imaging of the patient and/or the surgical site and/or anatomic landmarks and/or pathologic structures and/or tissues (e.g. damaged or diseased cartilage or exposed subchondral bone) and/or the surgeon or interventionalist's hands and/or fingers and/or the OR table and/or reference areas or points and/or marker, e.g. optical markers, in the operating room and/or on the patient and/or on the surgical field”),
receiving, using the computing system (“computer system with one or more processors” of [0005]), one or more second layer input data from one or more second devices ([0066], [0081] and [0099] disclose acquiring data from computed tomography, magnetic resonance imaging, among other medical imaging modalities to generate virtual data for display on the OHMD), the one or more second layer input data comprising at least one of (1) one or more patient sensor data for monitoring procedure-relevant aspects of the patient or (2) one or more patient imaging data comprising images of one or more portions of a body of the patient ([0099] states that “A computer system with one or more computer processors can then be used to display virtual data or virtual images from the time sequence of scans, images, image data sets, volume data sets, spirals obtained at the different time points, time intervals, time segments of the respiratory and/or cardiac cycle, e.g. from a pre-operative image acquisition or scan, that correspond to the phase of the respiratory or cardiac cycle of the patient, e.g. during an interventional procedure”);
generating, using the computing system(“computer system with one or more processors” of [0005]), one or more recommendations for guiding a medical professional in navigating one or more surgical devices toward, around, through, and/or within one or more soft tissue luminal portions of the patient to perform a soft tissue luminal procedure, based at least in part on the received one or more first layer input data and the received one or more second layer input data ([0304] discloses projecting a virtual path in the surgeon’s eyes through the display of the OHMD, where the virtual path is for navigation to soft tissue such as a vessel, heart or valve, according to [0344], using the virtual data [0344]),
the generated one or more recommendations comprising at least one multi-dimensional mapped guide toward, in, and/or around the one or more soft tissue luminal portions of the patient ([0108]-[0109] disclose that the mixed reality environment of the system allows for displaying on an optical head mounted device (OHMD), a virtual surgical guide, start point/position/orientation, intermediate point/position/orientation, and end point/position/orientation of a virtual surgical tool, the surgical tool being a tracked catheter in 3D space according to [0096], such positions/location/orientation being determined from imaging studies according to [0110]-[0111] and registration of the OHMD, patient and surgical tool within a common coordinate frame according to [0155]),
wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices ([0344] states that “a virtual surgical guide and/or any virtual placement indicators for a physical surgical guide can be projected by one or more OHMDs so that at least portions of the virtual surgical guide and/or virtual placement indicators (e.g. a virtual path, e.g. for a catheter) are tangent with, intersecting with and/or offset with a normal, damaged and/or diseased organ, tissue, tissue surface, vessel, heart, valve of the patient”, the virtual placement indicators being the graphical element for representing positions of the catheter during the interventional navigation),
the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions ([0066] states that “The terms “virtual data” or “virtual image” as used throughout the specification can include virtual 3D models, e.g. virtual 3D models extracted from or generated based on scans, images, image data sets, volume data sets, spirals, e.g. from pre- or intra-operative imaging, e.g. ultrasound, CT, MRI, SPECT, PET, echocardiography, CTA, MRA”. That is the virtual data that is used in generating the virtual surgical guide relies on 3D image data), and
the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient ([0344] disclose that the target tissue is a heart or blood vessel. [0030] further discloses the target tissue as including “a lung, a liver, a spleen, a pancreas, a gallbladder, a kidney, a tumor, a lesion, or combinations thereof”);
generating, using the computing system, one or more image-based outputs, the one or more image-based outputs comprising the multi-dimensional mapped guide([0304] discloses projecting a virtual path in the surgeon’s eyes through the display of the OHMD, where the virtual path is for navigation to soft tissue such as a vessel, heart or valve, according to [0344], using the virtual data [0344]); and
presenting, using the computing system and using a user experience ("UX") device, the generated one or more image-based outputs ([0109] states that “the OHMD can display one or more of a virtual surgical tool, virtual surgical instrument including a virtual surgical guide”, the display of the OHMD being the user experience device).
Lang does not teach the one or more first devices being physically separate from a user experience ("UX") device, and the one or more sensors comprising one or more room-based contactless sensors configured to map the entire room and to capture movement of the patient, the one or more persons other than the patient, and the one or more objects within the room; and the multi-dimensional mapped guide, including at least one of the target or the trajectory represented by the graphical element, is dynamically adjusted, in real-time or near-real-time during the soft tissue luminal procedure, in response to detected movement of at least one of the one or more persons other than the patient or the one or more objects within the room.
However, within the same field of endeavor, Exposito teaches a viewing system for use in a surgical environment, wherein various real object detection devices detect locations of real objects in a real environment, such as a patient and body part of patient, medical staff, robots, a cutting tool on a robot, implant transferred by robot into body part, surgical tools, and disposable items. A map generator generates a map that forms a digital representation or a digital twin of the real environment (see abstract). Exposito further teaches one or more first devices (movable sensors 436 and fixed sensors 434 of fig. 37 and [0192]) being physically separate from a user experience ("UX") device (personal computers 442 and tablet 444 of [0192]), and the one or more sensors comprising one or more room-based contactless sensors configured to map the entire room ([0203]) and to capture movement of the patient, the one or more persons other than the patient, and the one or more objects within the room ([0194] discloses that The fixed sensors 434 may be used to detect stationary objects within the room or, more commonly, objects that move within the room, such as surgical personnel, a robot, a cutting tool on the robot, a surgical implant, surgical tools, disposable items, a patient, and a body part of a patient); and the multi-dimensional mapped guide, including at least one of the target or the trajectory represented by the graphical element, is dynamically adjusted, in real-time or near-real-time during the soft tissue luminal procedure, in response to detected movement of at least one of the one or more persons other than the patient or the one or more objects within the room ([0037] discloses updating medical images of current surgical position when a current location of a surgeon changes. [0012] also describes that the images provide real time tracking of locations of ablative instruments).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Lang, the one or more first devices being physically separate from a user experience ("UX") device, and the one or more sensors comprising one or more room-based contactless sensors configured to map the entire room and to capture movement of the patient, the one or more persons other than the patient, and the one or more objects within the room; and the multi-dimensional mapped guide, including at least one of the target or the trajectory represented by the graphical element, is dynamically adjusted, in real-time or near-real-time during the soft tissue luminal procedure, in response to detected movement of at least one of the one or more persons other than the patient or the one or more objects within the room, as taught by Galloway, such that tumors and lesions in the tissue of a living patient can be accurately located, and resected or ablated with a precisely tracked ablative instrument ([0010]-[0012]).
Lang in view of Galloway fails to teach that the one or more recommendations is based at least in part on a combined analysis of (a) the received one or more first layer input data comprising the data indicative of at least one of movement, position, or relative distance for at least the one or more persons other than the patient and the one or more objects within the room and (b) the received one or more second layer input data.
However, within the same field of endeavor, Nagao teaches a medical arm system that supports a medical instrument, and adapts a position and posture of the medical instrument with respect to a point on action on the medical instrument. The system also includes a control unit configured to generate or to update mapping information mapping the space surrounding the point of action on a basis of the environment information acquired by the one or more acquisition units and arm state information representing the position and the posture of the medical instrument with respect to the point of action according to a state of the arm unit (see abstract). Nagao teaches the one or more recommendations ([0198] discloses an environment map) based at least in part on a combined analysis ([0200] discloses combination of image data and kinematic data for reconstructing a three-dimensional space of the operation site) of (a) the received one or more first layer input data comprising the data indicative of at least one of movement, position, or relative distance for at least the one or more persons other than the patient and the one or more objects within the room ([0201]-[0203]) and (b) the received one or more second layer input data ([0061] discloses images of the operation site as a second layer input data).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Lang, as modified by Galloway, wherein the one or more recommendations is based at least in part on a combined analysis of (a) the received one or more first layer input data comprising the data indicative of at least one of movement, position, or relative distance for at least the one or more persons other than the patient and the one or more objects within the room and (b) the received one or more second layer input data, as taught by Nagao, to improve real time determinations of locations of an instrument during image-guided surgery ([0006]-[0007]).
Regarding claim 2, Lang in view of Galloway and Nagao teaches all the limitations of claim 1 above.
Lang further teaches wherein the computing system comprises at least one of a medical procedure computing system, a hub computing system, a three-dimensional ("3D") graphical processing unit, a cluster computing system, a four- dimensional ("4D") graphics computing system, a server computer, a cloud computing system, or a distributed computing system (a “computer system with one or more processors” is disclosed in [0005]).
Regarding claim 9, Lang in view of Galloway and Nagao teaches all the limitations of claim 1 above.
Lang further teaches wherein the one or more image-based outputs are presented to provide one or more of: a guide for the medical professional, a navigation tool during the soft tissue luminal procedure, a proximity detection tool during the soft tissue luminal procedure, a three-dimensional ("3D") or four-dimensional ("4D") visualization view of the one or more portions of the body of the patient, a 3D or 4D visualization view of a digital twin of at least one of a therapeutic tool, a diagnostic tool, or an imaging tool, a heads-up display of a digital twin of at least one of a therapeutic tool, a diagnostic tool, or an imaging tool, a heads-up display of at least one of the one or more first layer input data, a heads-up display of at least one of the one or more patient sensor data, a heads-up display of at least one of the one or more patient imaging data, a heads-up display of physiological data of the patient, or a heads-up display of procedure-related data of the patient ([0304] discloses projecting a virtual path in the surgeon’s eyes through the display of the OHMD, where the virtual path is for navigation to soft tissue such as a vessel, heart or valve, according to [0344], using the virtual data [0344]).
Regarding claim 14, Lang in view of Galloway and Nagao teaches all the limitations of claim 1 above.
Lang further teaches wherein the method is performed without use of fluoroscopy ([0066] lists imaging modalities for creating the “virtual data” and “virtual image” used in the creation of the virtual 3D models of objects within the mixed reality environment ([0107]-[0108]), the list comprising ultrasound, CT, MRI, SPECT, PET, echocardiography, CTA, MRA, which does not include fluoroscopy).
Regarding claim 18, Lang teaches an apparatus, comprising: at least one processor system (“computer system with one or more processors” of [0005]); and a non-transitory computer readable medium communicatively coupled to the at least one processor, the non-transitory computer readable medium having stored thereon computer software comprising a set of instructions that, when executed by the at least one processor ([0635] discloses that “The computer or computer workstation can include one or more displays, keyboard, mouse, trackball, mousepad, joystick, human input devices, processor, graphics processors, memory chips, storage media, disks, and software, for example for 3D reconstruction, surface displays, volume displays or CAD design and display, as well as optional CAM output”), causes the apparatus to:
receive one or more first layer input data from one or more first devices comprising one or more sensors configured to map a room that includes at least the patient and one or more persons other than the patient, the one or more first layer input data comprising data indicative of at least one of movement, position, or relative distance for at least the one or more persons other than the patient and one or more objects within the room based on sensor data captured external to the patient and the one or more persons other than the patient by the one or more sensos configured to map the room ([0314] Live data, e.g. live data of the patient, the position and/or orientation of a physical instrument, the position and/or orientation of an implant component, the position and/or orientation of one or more OHMD's, can be acquired or registered, for example, using a spatial mapping process. This process creates a three-dimensional mesh describing the surfaces of one or more objects or environmental structures using, for example and without limitation, a depth sensor, laser scanner, structured light sensor, time of flight sensor, infrared sensor, or tracked probe. These devices can generate 3D surface data by collecting, for example, 3D coordinate information or information on the distance from the sensor of one or more surface points on the one or more objects or environmental structures. The 3D surface points can then be connected to 3D surface meshes, resulting in a three-dimensional surface representation of the live data. [0235] also states that “3D scanning can be used for imaging of the patient and/or the surgical site and/or anatomic landmarks and/or pathologic structures and/or tissues (e.g. damaged or diseased cartilage or exposed subchondral bone) and/or the surgeon or interventionalist's hands and/or fingers and/or the OR table and/or reference areas or points and/or marker, e.g. optical markers, in the operating room and/or on the patient and/or on the surgical field”),
receive one or more second layer input data from one or more second devices([0066], [0081] and [0099] disclose acquiring data from computed tomography, magnetic resonance imaging, among other medical imaging modalities to generate virtual data for display on the OHMD), the one or more second layer input data comprising at least one of (1) one or more patient sensor data for monitoring procedure- relevant aspects of the patient or (2) one or more patient imaging data comprising images of one or more portions of a body of the patient ([0099] states that “A computer system with one or more computer processors can then be used to display virtual data or virtual images from the time sequence of scans, images, image data sets, volume data sets, spirals obtained at the different time points, time intervals, time segments of the respiratory and/or cardiac cycle, e.g. from a pre-operative image acquisition or scan, that correspond to the phase of the respiratory or cardiac cycle of the patient, e.g. during an interventional procedure”);
generate one or more recommendations for guiding a medical professional in navigating one or more surgical devices toward, around, through, and/or within one or more soft tissue luminal portions of the patient to perform a soft tissue luminal procedure, based at least in part on the received one or more first layer input data and the received one or more second layer input data ([0304] discloses projecting a virtual path in the surgeon’s eyes through the display of the OHMD, where the virtual path is for navigation to soft tissue such as a vessel, heart or valve, according to [0344], using the virtual data [0344]),
the generated one or more recommendations comprising at least one multi-dimensional mapped guide toward, in, and/or around the one or more soft tissue luminal portions of the patient ([0108]-[0109] disclose that the mixed reality environment of the system allows for displaying on an optical head mounted device (OHMD), a virtual surgical guide, start point/position/orientation, intermediate point/position/orientation, and end point/position/orientation of a virtual surgical tool, the surgical tool being a tracked catheter in 3D space according to [0096], such positions/location/orientation being determined from imaging studies according to [0110]-[0111] and registration of the OHMD, patient and surgical tool within a common coordinate frame according to [0155]),
wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices ([0344] states that “a virtual surgical guide and/or any virtual placement indicators for a physical surgical guide can be projected by one or more OHMDs so that at least portions of the virtual surgical guide and/or virtual placement indicators (e.g. a virtual path, e.g. for a catheter) are tangent with, intersecting with and/or offset with a normal, damaged and/or diseased organ, tissue, tissue surface, vessel, heart, valve of the patient”, the virtual placement indicators being the graphical element for representing positions of the catheter during the interventional navigation),
the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions ([0066] states that “The terms “virtual data” or “virtual image” as used throughout the specification can include virtual 3D models, e.g. virtual 3D models extracted from or generated based on scans, images, image data sets, volume data sets, spirals, e.g. from pre- or intra-operative imaging, e.g. ultrasound, CT, MRI, SPECT, PET, echocardiography, CTA, MRA”. That is the virtual data that is used in generating the virtual surgical guide relies on 3D image data), and
the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient ([0344] disclose that the target tissue is a heart or blood vessel. [0030] further discloses the target tissue as including “a lung, a liver, a spleen, a pancreas, a gallbladder, a kidney, a tumor, a lesion, or combinations thereof”);
generate one or more image-based outputs, the one or more image-based outputs comprising the multi-dimensional mapped guide([0304] discloses projecting a virtual path in the surgeon’s eyes through the display of the OHMD, where the virtual path is for navigation to soft tissue such as a vessel, heart or valve, according to [0344], using the virtual data [0344]); and
present, using a user experience ("UX") device, the generated one or more image-based outputs ([0109] states that “the OHMD can display one or more of a virtual surgical tool, virtual surgical instrument including a virtual surgical guide”, the display of the OHMD being the user experience device).
Lang does not teach the one or more first devices being physically separate from a user experience ("UX") device, and the one or more sensors comprising one or more room-based contactless sensors configured to map the entire room and to capture movement of the patient, the one or more persons other than the patient, and the one or more objects within the room; and the multi-dimensional mapped guide, including at least one of the target or the trajectory represented by the graphical element, is dynamically adjusted, in real-time or near-real-time during the soft tissue luminal procedure, in response to detected movement of at least one of the one or more persons other than the patient or the one or more objects within the room.
However, within the same field of endeavor, Exposito teaches a viewing system for use in a surgical environment, wherein various real object detection devices detect locations of real objects in a real environment, such as a patient and body part of patient, medical staff, robots, a cutting tool on a robot, implant transferred by robot into body part, surgical tools, and disposable items. A map generator generates a map that forms a digital representation or a digital twin of the real environment (see abstract). Exposito further teaches one or more first devices (movable sensors 436 and fixed sensors 434 of fig. 37 and [0192]) being physically separate from a user experience ("UX") device (personal computers 442 and tablet 444 of [0192]), and the one or more sensors comprising one or more room-based contactless sensors configured to map the entire room ([0203]) and to capture movement of the patient, the one or more persons other than the patient, and the one or more objects within the room ([0194] discloses that The fixed sensors 434 may be used to detect stationary objects within the room or, more commonly, objects that move within the room, such as surgical personnel, a robot, a cutting tool on the robot, a surgical implant, surgical tools, disposable items, a patient, and a body part of a patient); and the multi-dimensional mapped guide, including at least one of the target or the trajectory represented by the graphical element, is dynamically adjusted, in real-time or near-real-time during the soft tissue luminal procedure, in response to detected movement of at least one of the one or more persons other than the patient or the one or more objects within the room ([0037] discloses updating medical images of current surgical position when a current location of a surgeon changes. [0012] also describes that the images provide real time tracking of locations of ablative instruments).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Lang, the one or more first devices being physically separate from a user experience ("UX") device, and the one or more sensors comprising one or more room-based contactless sensors configured to map the entire room and to capture movement of the patient, the one or more persons other than the patient, and the one or more objects within the room; and the multi-dimensional mapped guide, including at least one of the target or the trajectory represented by the graphical element, is dynamically adjusted, in real-time or near-real-time during the soft tissue luminal procedure, in response to detected movement of at least one of the one or more persons other than the patient or the one or more objects within the room, as taught by Galloway, such that tumors and lesions in the tissue of a living patient can be accurately located, and resected or ablated with a precisely tracked ablative instrument ([0010]-[0012]).
Lang in view of Galloway fails to teach that the one or more recommendations is based at least in part on a combined analysis of (a) the received one or more first layer input data comprising the data indicative of at least one of movement, position, or relative distance for at least the one or more persons other than the patient and the one or more objects within the room and (b) the received one or more second layer input data.
However, within the same field of endeavor, Nagao teaches a medical arm system that supports a medical instrument, and adapts a position and posture of the medical instrument with respect to a point on action on the medical instrument. The system also includes a control unit configured to generate or to update mapping information mapping the space surrounding the point of action on a basis of the environment information acquired by the one or more acquisition units and arm state information representing the position and the posture of the medical instrument with respect to the point of action according to a state of the arm unit (see abstract). Nagao teaches the one or more recommendations ([0198] discloses an environment map) based at least in part on a combined analysis ([0200] discloses combination of image data and kinematic data for reconstructing a three-dimensional space of the operation site) of (a) the received one or more first layer input data comprising the data indicative of at least one of movement, position, or relative distance for at least the one or more persons other than the patient and the one or more objects within the room ([0201]-[0203]) and (b) the received one or more second layer input data ([0061] discloses images of the operation site as a second layer input data).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Lang, as modified by Galloway, wherein the one or more recommendations is based at least in part on a combined analysis of (a) the received one or more first layer input data comprising the data indicative of at least one of movement, position, or relative distance for at least the one or more persons other than the patient and the one or more objects within the room and (b) the received one or more second layer input data, as taught by Nagao, to improve real time determinations of locations of an instrument during image-guided surgery ([0006]-[0007]).
Regarding claim 19, Lang teaches a system, comprising: a computing system, comprising:
at least one first processor (“computer system with one or more processors” of [0005]); and a first non-transitory computer readable medium communicatively coupled to the at least one first processor, the first non-transitory computer readable medium having stored thereon computer software comprising a first set of instructions that, when executed by the at least one first processor([0635] discloses that “The computer or computer workstation can include one or more displays, keyboard, mouse, trackball, mousepad, joystick, human input devices, processor, graphics processors, memory chips, storage media, disks, and software, for example for 3D reconstruction, surface displays, volume displays or CAD design and display, as well as optional CAM output”), causes the computing system to:
receive one or more first layer input data from one or more first devices comprising one or more sensors configured to map a room that includes at least the patient and one or more persons other than the patient, the one or more first layer input data comprising data indicative of at least one of movement, position, or relative distance for at least the one or more persons other than the patient and one or more objects within the room based on sensor data captured external to the patient and the one or more persons other than the patient by the one or more sensos configured to map the room ([0314] Live data, e.g. live data of the patient, the position and/or orientation of a physical instrument, the position and/or orientation of an implant component, the position and/or orientation of one or more OHMD's, can be acquired or registered, for example, using a spatial mapping process. This process creates a three-dimensional mesh describing the surfaces of one or more objects or environmental structures using, for example and without limitation, a depth sensor, laser scanner, structured light sensor, time of flight sensor, infrared sensor, or tracked probe. These devices can generate 3D surface data by collecting, for example, 3D coordinate information or information on the distance from the sensor of one or more surface points on the one or more objects or environmental structures. The 3D surface points can then be connected to 3D surface meshes, resulting in a three-dimensional surface representation of the live data. [0235] also states that “3D scanning can be used for imaging of the patient and/or the surgical site and/or anatomic landmarks and/or pathologic structures and/or tissues (e.g. damaged or diseased cartilage or exposed subchondral bone) and/or the surgeon or interventionalist's hands and/or fingers and/or the OR table and/or reference areas or points and/or marker, e.g. optical markers, in the operating room and/or on the patient and/or on the surgical field”),
receive one or more second layer input data from one or more second devices([0066], [0081] and [0099] disclose acquiring data from computed tomography, magnetic resonance imaging, among other medical imaging modalities to generate virtual data for display on the OHMD), the one or more second layer input data comprising at least one of (1) one or more patient sensor data comprising procedure- relevant aspects of the patient or (2) one or more patient imaging data for monitoring images of one or more portions of a body of the patient ([0099] states that “A computer system with one or more computer processors can then be used to display virtual data or virtual images from the time sequence of scans, images, image data sets, volume data sets, spirals obtained at the different time points, time intervals, time segments of the respiratory and/or cardiac cycle, e.g. from a pre-operative image acquisition or scan, that correspond to the phase of the respiratory or cardiac cycle of the patient, e.g. during an interventional procedure”);
generate one or more recommendations for guiding a medical professional in navigating one or more surgical devices toward, around, through, and/or within one or more soft tissue luminal portions of the patient to perform a soft tissue luminal procedure, based at least in part on the received one or more first layer input data and the received one or more second layer input data ([0304] discloses projecting a virtual path in the surgeon’s eyes through the display of the OHMD, where the virtual path is for navigation to soft tissue such as a vessel, heart or valve, according to [0344], using the virtual data [0344]),
the generated one or more recommendations comprising at least one multi-dimensional mapped guide toward, in, and/or around the one or more soft tissue luminal portions of the patient ([0108]-[0109] disclose that the mixed reality environment of the system allows for displaying on an optical head mounted device (OHMD), a virtual surgical guide, start point/position/orientation, intermediate point/position/orientation, and end point/position/orientation of a virtual surgical tool, the surgical tool being a tracked catheter in 3D space according to [0096], such positions/location/orientation being determined from imaging studies according to [0110]-[0111] and registration of the OHMD, patient and surgical tool within a common coordinate frame according to [0155]),
wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices ([0344] states that “a virtual surgical guide and/or any virtual placement indicators for a physical surgical guide can be projected by one or more OHMDs so that at least portions of the virtual surgical guide and/or virtual placement indicators (e.g. a virtual path, e.g. for a catheter) are tangent with, intersecting with and/or offset with a normal, damaged and/or diseased organ, tissue, tissue surface, vessel, heart, valve of the patient”, the virtual placement indicators being the graphical element for representing positions of the catheter during the interventional navigation),
the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions ([0066] states that “The terms “virtual data” or “virtual image” as used throughout the specification can include virtual 3D models, e.g. virtual 3D models extracted from or generated based on scans, images, image data sets, volume data sets, spirals, e.g. from pre- or intra-operative imaging, e.g. ultrasound, CT, MRI, SPECT, PET, echocardiography, CTA, MRA”. That is the virtual data that is used in generating the virtual surgical guide relies on 3D image data), and
the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient ([0344] disclose that the target tissue is a heart or blood vessel. [0030] further discloses the target tissue as including “a lung, a liver, a spleen, a pancreas, a gallbladder, a kidney, a tumor, a lesion, or combinations thereof”);
generate one or more image-based outputs, the one or more image-based outputs comprising the multi-dimensional mapped guide([0304] discloses projecting a virtual path in the surgeon’s eyes through the display of the OHMD, where the virtual path is for navigation to soft tissue such as a vessel, heart or valve, according to [0344], using the virtual data [0344]); and
present, using a user experience ("UX") device, the generated one or more image-based outputs ([0109] states that “the OHMD can display one or more of a virtual surgical tool, virtual surgical instrument including a virtual surgical guide”, the display of the OHMD being the user experience device).
Lang does not teach the one or more first devices being physically separate from a user experience ("UX") device, and the one or more sensors comprising one or more room-based contactless sensors configured to map the entire room and to capture movement of the patient, the one or more persons other than the patient, and the one or more objects within the room; and the multi-dimensional mapped guide, including at least one of the target or the trajectory represented by the graphical element, is dynamically adjusted, in real-time or near-real-time during the soft tissue luminal procedure, in response to detected movement of at least one of the one or more persons other than the patient or the one or more objects within the room.
However, within the same field of endeavor, Exposito teaches a viewing system for use in a surgical environment, wherein various real object detection devices detect locations of real objects in a real environment, such as a patient and body part of patient, medical staff, robots, a cutting tool on a robot, implant transferred by robot into body part, surgical tools, and disposable items. A map generator generates a map that forms a digital representation or a digital twin of the real environment (see abstract). Exposito further teaches one or more first devices (movable sensors 436 and fixed sensors 434 of fig. 37 and [0192]) being physically separate from a user experience ("UX") device (personal computers 442 and tablet 444 of [0192]), and the one or more sensors comprising one or more room-based contactless sensors configured to map the entire room ([0203]) and to capture movement of the patient, the one or more persons other than the patient, and the one or more objects within the room ([0194] discloses that The fixed sensors 434 may be used to detect stationary objects within the room or, more commonly, objects that move within the room, such as surgical personnel, a robot, a cutting tool on the robot, a surgical implant, surgical tools, disposable items, a patient, and a body part of a patient); and the multi-dimensional mapped guide, including at least one of the target or the trajectory represented by the graphical element, is dynamically adjusted, in real-time or near-real-time during the soft tissue luminal procedure, in response to detected movement of at least one of the one or more persons other than the patient or the one or more objects within the room ([0037] discloses updating medical images of current surgical position when a current location of a surgeon changes. [0012] also describes that the images provide real time tracking of locations of ablative instruments).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Lang, the one or more first devices being physically separate from a user experience ("UX") device, and the one or more sensors comprising one or more room-based contactless sensors configured to map the entire room and to capture movement of the patient, the one or more persons other than the patient, and the one or more objects within the room; and the multi-dimensional mapped guide, including at least one of the target or the trajectory represented by the graphical element, is dynamically adjusted, in real-time or near-real-time during the soft tissue luminal procedure, in response to detected movement of at least one of the one or more persons other than the patient or the one or more objects within the room, as taught by Galloway, such that tumors and lesions in the tissue of a living patient can be accurately located, and resected or ablated with a precisely tracked ablative instrument ([0010]-[0012]).
Lang in view of Galloway fails to teach that the one or more recommendations is based at least in part on a combined analysis of (a) the received one or more first layer input data comprising the data indicative of at least one of movement, position, or relative distance for at least the one or more persons other than the patient and the one or more objects within the room and (b) the received one or more second layer input data.
However, within the same field of endeavor, Nagao teaches a medical arm system that supports a medical instrument, and adapts a position and posture of the medical instrument with respect to a point on action on the medical instrument. The system also includes a control unit configured to generate or to update mapping information mapping the space surrounding the point of action on a basis of the environment information acquired by the one or more acquisition units and arm state information representing the position and the posture of the medical instrument with respect to the point of action according to a state of the arm unit (see abstract). Nagao teaches the one or more recommendations ([0198] discloses an environment map) based at least in part on a combined analysis ([0200] discloses combination of image data and kinematic data for reconstructing a three-dimensional space of the operation site) of (a) the received one or more first layer input data comprising the data indicative of at least one of movement, position, or relative distance for at least the one or more persons other than the patient and the one or more objects within the room ([0201]-[0203]) and (b) the received one or more second layer input data ([0061] discloses images of the operation site as a second layer input data).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Lang, as modified by Galloway, wherein the one or more recommendations is based at least in part on a combined analysis of (a) the received one or more first layer input data comprising the data indicative of at least one of movement, position, or relative distance for at least the one or more persons other than the patient and the one or more objects within the room and (b) the received one or more second layer input data, as taught by Nagao, to improve real time determinations of locations of an instrument during image-guided surgery ([0006]-[0007]).
Regarding claim 20, Lang in view of Galloway and Nagao teaches all the limitations of claim 1 above.
Lang further teaches wherein the multi-dimensional mapped guide comprises auditory data, tactile data, and/or visual feedback ([0398] states that “when a view angle and/or a distance or a movement speed of an image and/or video capture system integrated into an OHMD indicate that a measurement value can fall outside two standard deviations of the system performance including overall system performance, it can trigger an alert to the surgeon or interventionalist that the display of virtual data, e.g. portions of a virtual surgical plan, virtual projected paths or virtual planes, e.g. virtual cut planes, may not be accurate”).
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lang in view of Galloway and Nagao, as applied to claim 1 above, and further in view of Shuros, et al., US 20180140328 A1.
Regarding claim 3, Lang in view of Galloway and Nagao teaches all the limitations of claim 1 above.
While Lang several multiple surgical devices such as stents, grafts, and cardiac valves in [0070], Lang in view of Galloway and Nagao does not explicitly state that these devices are leadless.
However, within the same field of endeavor, Shuros teaches delivering an implantable leadless pacing device that includes a catheter shaft and a distal holding section for receiving the implantable leadless pacing device (see abstract). [0059] states that a “delivery device 104 (e.g., a catheter) that may be used to deliver an implantable leadless cardiac pacing device 100 (e.g., a leadless pacemaker) in a chamber of a heart H, such as the right ventricle RV ([0059]), hence teaching the recited limitation of “wherein the one or more surgical devices comprise a miniature leadless device”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Lang, as modified by Galloway and Nagao, wherein the one or more surgical devices comprise a miniature leadless device, as taught by Shuros, as such modification would provide the clinician with displayed information regarding the surgical device for interventional decisions (see [0085]), with a reasonable expectation of success, as Lang, is strives to provide the clinician with such displayed information to guide the clinician during interventional procedures ([0003]).
Regarding claim 15, Lang in view of Galloway and Nagao teaches all the limitations of claim 1 above.
Lang further teaches wherein the method further comprises:
tracking, using the computing system (“computer system with one or more processors” of [0005]), a miniature device as the miniature device is navigated within the body of the patient ([0096] states “the first virtual object can be a catheter (e.g. a tracked catheter) and the first virtual object can be displayed inside at least a portion of a second virtual object which can be a virtual vessel, e.g. an artery or a vein. The movement of a tracked catheter can be displayed by the OHMD superimposed onto or inside a virtual display of the virtual vessel, e.g. the virtual artery or vein thereby allowing the interventionalist to see the movement of the tracked catheter in 3D in the OHMD display, for example as it enters a vascular ostium or an aneurysm”);
presenting, using the computing system and using the UX device, the generated one or more image-based outputs to guide, in real-time or near-real-time([0099] discloses real-time display of the virtual data including the virtual surgical guide by the OHMD), the medical professional in positioning ([0106] discloses displaying a surgical navigation of a virtual instrument or device) the miniature device ([0070] discloses that the virtual and/or physical devices or implants include pacemakers) within one or more predetermined or real-time adjusted targeted locations within the heart ([0030] discloses the heart the target of intervention), which is in motion due to expected cardiac activity data ([0304] discloses projecting a the virtual surgical field, virtual surgical plane, virtual paths, virtual cut paths or planes in the surgeon’s eyes through the display of the OHMD, where the virtual path is for navigation to soft tissue such as a vessel, heart or valve, according to [0344], using the virtual data [0344]. Of note, [0098]-[0099] describe synchronizing moving virtual data, that is, virtual data of the heart to orientations of the OHMD); and
presenting, using the computing system and using the UX device, the generated one or more image-based outputs to highlight, in real-time or near-real-time ([0099] discloses real-time display of the virtual data including the virtual surgical guide by the OHMD), at least one of the one or more targeted locations, one or more guided paths or trajectories toward each of the one or more targeted locations, or one or more portions of the heart or other organ structures to avoid ([0109] states that “the OHMD can display one or more of a virtual surgical tool, virtual surgical instrument including a virtual surgical guide”, the display of the OHMD being the UX device; and [0115] discloses displaying targeted locations. In both situations, the displaying on the OHMD highlights the object of interest).
Lang in view of Galloway and Nagao fails to teach wherein the soft tissue luminal procedure comprises a leadless ventricle from atrium sensing and pacing system procedure ("VFA procedure"), wherein the one or more surgical devices comprise a miniature leadless device; the miniature device is navigated through body via one of a jugular access or a femoral access, toward the heart of the patient.
However, within the same field of endeavor, Shuros teaches a delivery device 104 (e.g., a catheter) that may be used to deliver an implantable leadless cardiac pacing device 100 (e.g., a leadless pacemaker) in a chamber of a heart H, such as the right ventricle RV ([0059]), wherein the soft tissue luminal procedure comprises a leadless ventricle from atrium sensing and pacing system procedure ("VFA procedure") ([0058] states that “As an alternative to conventional pacemakers, self-contained or leadless cardiac pacemakers have been proposed. Leadless cardiac pacemakers are small capsules typically fixed to an intracardiac implant site in a cardiac chamber. The small capsule typically includes bipolar pacing/sensing electrodes, a power source (e.g. a battery), and associated electrical circuitry for controlling the pacing/sensing electrodes, and thus provide electrical stimulation to heart tissue and/or sense a physiological condition. The capsule may be delivered to the heart using a delivery device which may be advanced through a femoral vein, into the inferior vena cava, into the right atrium, through the tricuspid valve, and into the right ventricle”. This description comprises the recited “VFA procedure” being performed on a small or miniature capsule-like pacemaker), wherein the one or more surgical devices comprise a miniature leadless device ([0059] further indicates that the pacemaker is leadless), and that the miniature device is navigated through body via one of a jugular access or a femoral access, toward the heart of the patient (as noted above, [0058], discloses advancing the pacemaker into the heart through the femoral vein).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Lang, as modified by Galloway and Nagao, wherein the soft tissue luminal procedure comprises a leadless ventricle from atrium sensing and pacing system procedure ("VFA procedure"), wherein the one or more surgical devices comprise a miniature leadless device; the miniature device is navigated through body via one of a jugular access or a femoral access, toward the heart of the patient, as taught by Shuros, as such modification would provide the clinician with displayed information regarding the surgical device for interventional decisions (see [0085]), with a reasonable expectation of success, as Lang, is strives to provide the clinician with such displayed information to guide the clinician during interventional procedures ([0003]).
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lang in view of Galloway, Nagao, and Shuros, as applied to claim 15 above, and further in view of Ghosh, S., US 20190262617 A1.
Regarding claim 16, Lang in view of Galloway, Nagao, and Shuros teaches all the limitations of claim 15.
Lang in view of Galloway, Nagao, and Shuros fails to teach sending, using the computing system, one or more sets of instructions generated by a programmer system, the one or more sets of instructions being configured to program one or more settings or configurations of the miniature leadless device, wherein the one or more settings or configurations of the miniature leadless device comprise at least one of pacing mode, rate limits, stimulation parameters, sensing parameters, rate response parameters, or other parameters related to operation of the miniature leadless device.
However, within the same field of endeavor, Ghosh teaches a method of delivering a cardiac pacing therapy (see [0057] and fig. 5), the therapy including a leadless pacing device including integrated electromechanical sensor, such as an accelerometer, whose signal can be representative of various mechanical events that occur during the contraction/relaxation cycle of a ventricle of the patient's heart according to [0005] and further including sending, using the computing system, one or more sets of instructions generated by a programmer system ([0046] states that “the memory 232 may include pacing instructions and values, such as the baseline atrial pacing rate, the baseline atrial pacing interval and the baseline AV interval. The pacing instructions and values may be updated by the programmer 212 (FIG. 1). Pacing instructions included in the memory 232 may cause the leadless pacemaker device 202 to operate as described herein”), the one or more sets of instructions being configured to program one or more settings or configurations of the miniature leadless device ([0043] states that “FIG. 3 shows a system including a leadless pacemaker device 202 positioned in the atrium 204 of the heart 206, a leadless pacemaker device 202 positioned within the ventricle 210 of the heart 206, and a programmer 212 that may be used to program one or both leadless pacemaker device 202 and/or to retrieve data from one or both leadless pacemaker device 202”),
wherein the one or more settings or configurations of the miniature leadless device comprise at least one of pacing mode, rate limits, stimulation parameters, sensing parameters, rate response parameters, or other parameters related to operation of the miniature leadless device ([0046] states “the memory 232 may include pacing instructions and values, such as the baseline atrial pacing rate, the baseline atrial pacing interval and the baseline AV interval. The pacing instructions and values may be updated by the programmer 212 (FIG. 1)”, and [0058] discloses adjusting the pacing rate if dyssyncrhony is determined).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Lang, as modified by Galloway, Nagao, and Shuros for sending, using the computing system, one or more sets of instructions generated by a programmer system, the one or more sets of instructions being configured to program one or more settings or configurations of the miniature leadless device, wherein the one or more settings or configurations of the miniature leadless device comprise at least one of pacing mode, rate limits, stimulation parameters, sensing parameters, rate response parameters, or other parameters related to operation of the miniature leadless device, as taught by Ghosh, as such modification would improve patient outcomes through the improved detection and correction of irregular heart functions ([0004]), with a reasonable expectation of success, as Lang is strives to provide the clinician with such displayed information to guide the clinician during interventional procedures ([0003]), which in turn, would improve patient outcomes.
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Lang in view of Galloway, Nagao, and Shuros, as applied to claim 15 above, and further in view of Mangual-Soto, et al., US 20230008264 A1
Regarding claim 17, Lang in view of Galloway, Nagao, and Shuros teaches all the limitations of claim 15.
Lang in view of Galloway, Nagao, and Shuros fails to teach wherein navigating the miniature leadless device within the body of the patient is performed using one or more robotic systems controlled by one or more control inputs received from the medical professional via the computing system.
However, within the same field of endeavor, Mangual-Soto discloses a process 500 of fig. 5 and [0072] for determining when an electrode has reached a target depth when penetrating a septal wall during implant ([0072]), the implant comprising a leadless implantable device (LIMD) according [0026], wherein navigating the miniature leadless device within the body of the patient is performed using one or more robotic systems controlled by one or more control inputs received from the medical professional via the computing system ([0090] states that “If at 512 the one or more processors determine the first electrode is located at the target depth within the septal wall based on the impedance data, then at 514, the one or more processors communicate that the target depth has been reached…where a robotic arm or device is being utilized to facilitate insertion, the robotic arm may deactivate”. That is, the insertion is performed using a robotic system, with [0090] further stating that “a manner of communicating that the target depth has been reached is presented, assisting the surgeon in placement of the first electrode proximate the LBB without perforating the distal portion of the LV septum side wall. Consequently, the implanting of the medical device is improved by providing more accuracy and safety”. Of note, [0107] indicates that the processes described herein, including the use of the robotic system, are performed under the control of the one or more computer systems, at least suggesting the one or more control inputs for the robotic system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Lang, as modified by Galloway, Nagao, and Shuros, wherein navigating the miniature leadless device within the body of the patient is performed using one or more robotic systems controlled by one or more control inputs received from the medical professional via the computing system, as taught by Mangual-Soto, providing improved accuracy and safety ([0090]), with a reasonable expectation of success, as Lang, is strives to provide the clinician with such displayed information to guide the clinician during interventional procedures ([0003]).
Double Patenting
The nonstatutory provisional double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory provisional double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 9, 14, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9, and 14-16 of copending Application No. 17/700622 (U.S. P.G. Pub. No. US 20220361954 A1 A1) in view of Schotzko, et al., US 20190307516 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations recited in the claims mentioned above of the instant application are also recited in the claims mentioned above of the copending application.
Instant Application
Copending Application 17/700622
1. (Currently Amended) A method for presenting patient information to a user, comprising: receiving, using a computing system, one or more first layer input data from one or more first devices, the one or more first layer input data comprising data indicative of at least one of movement, position, or relative distance for one or more persons other than a patient and one or more objects within a room;
receiving, using the computing system, one or more second layer input data from one or more second devices, the one or more second layer input data comprising at least one of (1) one or more patient sensor data for monitoring procedure-relevant aspects of a patient or (2) one or more patient imaging data for monitoring images of one or more portions of a body of the patient;
analyzing, using the computing system, the received one or more first layer input data and the received one or more second layer input; generating, using the computing system, one or more recommendations for guiding a medical professional in navigating one or more surgical devices toward, around, through, and/or within one or more soft tissue luminal portions of the patient to perform a soft tissue luminal procedure, based at least in part on the analysis, and the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient;
the generated one or more recommendations comprising at least one multi-dimensional mapped guide toward, in, and/or around the one or more soft tissue luminal portions of the patient,
generating, using the computing system, one or more image-based outputs, the one or more image-based outputs comprising the multi-dimensional mapped guide; and presenting, using the computing system and using a user experience ("UX") device, the generated one or more image-based outputs.
1. A method, comprising:
receiving, using a computing system, one or more first layer input data from one or more first devices, the one or more first layer input data comprising at least one of movement data, position data, relative distance data, or externally observable data for each of one or more persons and one or more objects within a room;
receiving, using the computing system, one or more second layer input data from one or more second devices, the one or more second layer input data comprising at least one of one or more patient sensor data for monitoring procedure-relevant aspects of a patient, one or more patient imaging data for monitoring images of one or more portions of a body of the patient, or one or more navigation and mapping data for monitoring one or more surgical devices relative to the one or more portions of the body of the patient, one or more patient imaging data for monitoring images of one or more portions of a body of the patient;
analyzing, using the computing system, the received one or more first layer input data and the received one or more second layer input; generating, using the computing system, one or more recommendations for guiding a medical professional in performing a cardiac implantable electronic device ("CIED") placement procedure in a heart of the patient, based at least in part on the analysis,
the generated one or more recommendations comprising three-dimensional ("3D") or four-dimensional ("4D") mapped guides toward, in, and around the heart of the patient;
generating, using the computing system, one or more extended reality ("XR") images, based at least in part on the generated one or more recommendations; and presenting, using the computing system and using a user experience ("UX") device, the generated one or more XR images.
17/700622 fails to teach that the one or more first layer input data is based on one or more images captured external to the patient; and wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices, the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions.
However, Schotzko teaches a method of guiding an instrument and presenting the guidance process on a graphical user interface (GUI) (paragraph 33) and fig. 3A and paragraph 57 demonstrate the trajectory of a medical instrument within the region of interest, that is the heart according to paragraph 37, as represented on the GUI, in 3D image data.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure 17/700622 such that the one or more first layer input data is based on one or more images captured external to the patient; and wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices, the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions, as taught by Schotzko, as such modification would allow a more efficient way to guide medical device to a targeted tissue area for medical treatment (paragraphs 4-6).
2. (Previously Presented) The method of claim 1, wherein the computing system comprises at least one of a medical procedure computing system, a hub computing system, a three-dimensional ("3D") graphical processing unit, a cluster computing system, a four- dimensional ("4D") graphics computing system, a server computer, a cloud computing system, or a distributed computing system.
2. The method of claim 1, wherein the computing system comprises at least one of an XR computing system, a medical procedure computing system, a hub computing system, a 3D graphical processing unit, a cluster computing system, a 4D graphics computing system, a server computer, a cloud computing system, or a distributed computing system.
3. (Currently Amended) The method of claim 1, wherein the one or more surgical devices comprise a miniature leadless device.
3. The method of claim 1, wherein the one or more surgical devices comprise at least one of…a miniature leadless implant,… a leadless bradycardia pacemaker,…or one or more capital equipment.
9. (Previously Presented) The method of claim 1, wherein the one or more image- based outputs are presented to provide one or more of: a guide for the medical professional, a navigation tool during the soft tissue luminal procedure,
a proximity detection tool during the soft tissue luminal procedure, a three-dimensional ("3D") or four-dimensional ("4D") visualization view of the one or more portions of the body of the patient, a 3D or 4D visualization view of a digital twin of at least one of a therapeutic tool, a diagnostic tool, or an imaging tool, a heads-up display of a digital twin of at least one of a therapeutic tool, a diagnostic tool, or an imaging tool, a heads-up display of at least one of the one or more first layer input data, a heads-up display of at least one of the one or more patient sensor data, a heads-up display of at least one of the one or more patient imaging data, a heads-up display of physiological data of the patient, or a heads-up display of procedure-related data of the patient.
9. The method of claim 1, wherein the generated one or more XR images are presented to provide one or more of: a guide for the medical professional, a navigation tool during the CIED placement procedure,
a proximity detection tool during the CIED placement procedure, a 3D or 4D visualization view of the at least one or more portions of the patient, a heads-up display of at least one of the one or more first layer input data, a heads-up display of at least one of the one or more patient sensor data, a heads-up display of at least one of the one or more patient imaging data, a heads-up display of physiological data of the patient, or a heads-up display of procedure-related data of the patient.
14. (Original) The method of claim 1, wherein the method is performed without use of fluoroscopy.
14. The method of claim 1, wherein the method is performed without use of fluoroscopy.
18. (Previously Presented) An apparatus, comprising: at least one processor; and a non-transitory computer readable medium communicatively coupled to the at least one processor, the non-transitory computer readable medium having stored thereon computer software comprising a set of instructions that, when executed by the at least one processor, causes the apparatus to:
receive one or more first layer input data from one or more first devices, the one or more first layer input data comprising data indicative of at least one of movement, position, or relative distance for one or more persons other than a patient and one or more objects within a room;
receive one or more second layer input data from one or more second devices, the one or more second layer input data comprising at least one of (1) one or more patient sensor data for monitoring procedure-relevant aspects of a patient or (2) one or more patient imaging data for monitoring images of one or more portions of a body of the patient;
analyze the received one or more first layer input data and the received one or more second layer input;
generate one or more recommendations for guiding a medical professional in navigating one or more surgical devices toward, around, through, and/or within one or more soft tissue luminal portions of the patient to perform a soft tissue luminal procedure, based at least in part on the analysis,
generate one or more image-based outputs, the one or more image-based outputs comprising the multi-dimensional mapped guide; and
present, using a user experience ("UX") device, the generated one or more image- based outputs.
15. An apparatus, comprising: at least one processor; and a non-transitory computer readable medium communicatively coupled to the at least one processor, the non-transitory computer readable medium having stored thereon computer software comprising a set of instructions that, when executed by the at least one processor, causes the apparatus to:
receive one or more first layer input data from one or more first devices, the one or more first layer input data comprising at least one of movement data, position data, relative distance data, or externally observable data for each of one or more persons and one or more objects within a room; receive one or more second layer input data from one or more second devices, the one or more second layer input data comprising at least one of one or more patient sensor data for monitoring procedure-relevant aspects of a patient, one or more patient imaging data for monitoring images of one or more portions of a body of the patient, or one or more navigation and mapping data for monitoring one or more surgical devices relative to the one or more portions of the body of the patient;
analyze the received one or more first layer input data and the received one or more second layer input;
generate one or more recommendations for guiding a medical professional in performing a cardiac implantable electronic device ("CIED") placement procedure in a heart of the patient, based at least in part on the analysis, the generated one or more recommendations comprising three-dimensional ("3D") or four-dimensional ("4D") mapped guides toward, in, and around the heart of the patient;
generate one or more extended reality ("XR") images, based at least in part on the generated one or more recommendations; and
present, using a user experience ("UX") device, the generated one or more XR images.
17/700622 fails to teach that the one or more first layer input data is based on one or more images captured external to the patient, the generated one or more recommendations comprising at least one multi-dimensional mapped guide toward, in, and/or around the one or more soft tissue luminal portions of the patient, wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices, the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions, and the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient.
However, Schotzko teaches a method of guiding an instrument and presenting the guidance process on a graphical user interface (GUI) (paragraph 33), paragraph 52 discloses providing a plan or map to guide a clinician including tracking of the surgical instrument within the body of the patient. Paragraph 33 indicates that the image data is a 3D image data and paragraph 68 indicates that 3D projections of the target zone within which treatment is implement is shown on the GUI; and fig. 3A and paragraph 57 demonstrate the trajectory of a medical instrument within the region of interest, that is the heart according to paragraph 37, as represented on the GUI, in 3D image data.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure 17/700622 such that the one or more first layer input data is based on one or more images captured external to the patient, the generated one or more recommendations comprising at least one multi-dimensional mapped guide toward, in, and/or around the one or more soft tissue luminal portions of the patient, wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices, the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions, and the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient, as taught by Schotzko, as such modification would allow a more efficient way to guide medical device to a targeted tissue area for medical treatment (paragraphs 4-6).
19. (Previously Presented) A system, comprising: a computing system, comprising: at least one first processor; and a first non-transitory computer readable medium communicatively coupled to the at least one first processor, the first non-transitory computer readable medium having stored thereon computer software comprising a first set of instructions that, when executed by the at least one first processor, causes the computing system to:
receive one or more first layer input data from one or more first devices, the one or more first layer input data comprising data indicative of at least one of movement, position, or relative distance for one or more persons other than a patient and one or more objects within a room;
receive one or more second layer input data from one or more second devices, the one or more second layer input data comprising at least one of (1) one or more patient sensor data for monitoring procedure- relevant aspects of a patient or (2) one or more patient imaging data for monitoring images of one or more portions of a body of the patient;
analyze the received one or more first layer input data and the received one or more second layer input; generate one or more recommendations for guiding a medical professional in navigating one or more surgical devices toward, around, through, and/or within one or more soft tissue luminal portions of the patient to perform a soft tissue luminal procedure, based at least in part on the analysis,
the generated one or more recommendations comprising at least one multi-dimensional mapped guide toward, in, and/or around the one or more soft tissue luminal portions of the patient,
generate one or more image-based outputs, the one or more image-based outputs comprising the multi-dimensional mapped guide; and present, using a user experience ("UX") device, the generated one or more image-based outputs.
16. A system, comprising: a computing system, comprising: at least one first processor; and a first non-transitory computer readable medium communicatively coupled to the at least one first processor, the first non-transitory computer readable medium having stored thereon computer software comprising a first set of instructions that, when executed by the at least one first processor, causes the computing system to:
receive one or more first layer input data from one or more first devices, the one or more first layer input data comprising at least one of movement data, position data, relative distance data, or externally observable data for each of one or more persons and one or more objects within a room;
receive one or more second layer input data from one or more second devices, the one or more second layer input data comprising at least one of one or more patient sensor data for monitoring procedure- relevant aspects of a patient, one or more patient imaging data for monitoring images of one or more portions of a body of the patient, or one or more navigation and mapping data for monitoring one or more surgical devices relative to the one or more portions of the body of the patient;
analyze the received one or more first layer input data and the received one or more second layer input; generate one or more recommendations for guiding a medical professional in performing a cardiac implantable electronic device ("CIED") placement procedure in a heart of the patient, based at least in part on the analysis,
the generated one or more recommendations comprising three-dimensional ("3D") or four-dimensional ("4D") mapped guides toward, in, and around the heart of the patient;
generate one or more extended reality ("XR") images, based at least in part on the generated one or more recommendations; and present, using a user experience ("UX") device, the generated one or more XR images.
17/700622 fails to teach the one or more first layer input data is based on one or more images captured external to the patient, the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices, the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions, and the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient;
However, Schotzko teaches a method of guiding an instrument and presenting the guidance process on a graphical user interface (GUI) (paragraph 33), paragraph 52 discloses providing a plan or map to guide a clinician including tracking of the surgical instrument within the body of the patient. Paragraph 33 indicates that the image data is a 3D image data and paragraph 68 indicates that 3D projections of the target zone within which treatment is implement is shown on the GUI; and fig. 3A and paragraph 57 demonstrate the trajectory of a medical instrument within the region of interest, that is the heart according to paragraph 37, as represented on the GUI, in 3D image data.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure 17/700622 such that the one or more first layer input data is based on one or more images captured external to the patient, the generated one or more recommendations comprising at least one multi-dimensional mapped guide toward, in, and/or around the one or more soft tissue luminal portions of the patient, wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices, the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions, and the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient, as taught by Schotzko, as such modification would allow a more efficient way to guide medical device to a targeted tissue area for medical treatment (paragraphs 4-6).
Claims 1-2, 9, 14, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 9, 14, and 17-18 of copending Application No. 17/974689 (U.S. P.G. Pub. No. US 20230157757 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations recited in the claims mentioned above of the instant application are also recited in the claims mentioned above of the copending application.
Instant Application
Copending Application 17/974689
1. (Currently Amended) A method for presenting patient information to a user, comprising:
receiving, using a computing system, one or more first layer input data from one or more first devices, the one or more first layer input data comprising data indicative of at least one of movement, position, or relative distance for one or more persons other than a patient and one or more objects within a room;
receiving, using the computing system, one or more second layer input data from one or more second devices, the one or more second layer input data comprising at least one of (1) one or more patient sensor data for monitoring procedure-relevant aspects of a patient or (2) one or more patient imaging data for monitoring images of one or more portions of a body of the patient;
analyzing, using the computing system, the received one or more first layer input data and the received one or more second layer input;
generating, using the computing system, one or more recommendations for guiding a medical professional in navigating one or more surgical devices toward, around, through, and/or within one or more soft tissue luminal portions of the patient to perform a soft tissue luminal procedure, based at least in part on the analysis,
the generated one or more recommendations comprising at least one multi-dimensional mapped guide toward, in, and/or around the one or more soft tissue luminal portions of the patient, the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions, and the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient;
generating, using the computing system, one or more image-based outputs, the one or more image-based outputs comprising the multi-dimensional mapped guide; and presenting, using the computing system and using a user experience ("UX") device, the generated one or more image-based outputs.
1. (Currently Amended) A method, comprising:
receiving, using a computing system, first layer input data for an artificial intelligence algorithm from one or more first devices, the first layer input data comprising at least one of movement data, position data, relative distance data, or externally observable data for each of one or more persons and one or more objects within a room;
receiving, using the computing system, second layer input data for the artificial intelligence algorithm from one or more second devices, the second layer input data comprising at least one of one or more patient sensor data for monitoring procedure-relevant aspects of a patient, one or more patient imaging data for monitoring images of one or more portions of a body of the patient, or one or more navigation and mapping data for monitoring one or more surgical devices relative to the one or more portions of the body of the patient, the patient being within the room;
analyzing, using the computing system, the received first layer input data and the received second layer input data based on the artificial intelligence algorithm;
generating, using the computing system, one or more recommendations for guiding a medical professional in guiding the one or more surgical devices toward and within a lung of the patient to perform a pulmonary procedure, based at least in part on the analysis,
the generated one or more recommendations comprising three-dimensional ("3D") or four-dimensional ("4D") mapped guides toward, in, and around the lung of the patient;
generating, using the computing system, one or more extended reality ("XR") images, based at least in part on the generated one or more recommendations; and presenting, using the computing system and using a user experience ("UX") device, the generated one or more XR images.
17/974689 fails to teach that the one or more first layer input data is based on one or more images captured external to the patient wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices.
However, Schotzko teaches a method of guiding an instrument and presenting the guidance process on a graphical user interface (GUI) (paragraph 33), paragraph 52 discloses providing a plan or map to guide a clinician including tracking of the surgical instrument within the body of the patient. Paragraph 33 indicates that the image data is a 3D image data and paragraph 68 indicates that 3D projections of the target zone within which treatment is implement is shown on the GUI; and fig. 3A and paragraph 57 demonstrate the trajectory of a medical instrument within the region of interest, that is the heart according to paragraph 37, as represented on the GUI, in 3D image data.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure 17/700622 such that the one or more first layer input data is based on one or more images captured external to the patient wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices, as taught by Schotzko, as such modification would allow a more efficient way to guide medical device to a targeted tissue area for medical treatment (paragraphs 4-6).
2. (Previously Presented) The method of claim 1, wherein the computing system comprises at least one of a medical procedure computing system, a hub computing system, a three-dimensional ("3D") graphical processing unit, a cluster computing system, a four- dimensional ("4D") graphics computing system, a server computer, a cloud computing system, or a distributed computing system.
2. (Original) The method of claim 1, wherein the computing system comprises at least one of an XR computing system, a medical procedure computing system, a hub computing system, a 3D graphical processing unit, a cluster computing system, a 4D graphics computing system, a server computer, a cloud computing system, or a distributed computing system.
9. (Previously Presented) The method of claim 1, wherein the one or more image- based outputs are presented to provide one or more of: a guide for the medical professional, a navigation tool during the soft tissue luminal procedure, a proximity detection tool during the soft tissue luminal procedure, a three-dimensional ("3D") or four-dimensional ("4D") visualization view of the one or more portions of the body of the patient, a 3D or 4D visualization view of a digital twin of at least one of a therapeutic tool, a diagnostic tool, or an imaging tool, a heads-up display of a digital twin of at least one of a therapeutic tool, a diagnostic tool, or an imaging tool, a heads-up display of at least one of the one or more first layer input data, a heads-up display of at least one of the one or more patient sensor data, a heads-up display of at least one of the one or more patient imaging data, a heads-up display of physiological data of the patient, or a heads-up display of procedure-related data of the patient.
9. (Currently Amended) The method of claim 1, wherein the generated one or more XR images are presented to provide one or more of: a guide for the medical professional, a navigation tool during the pulmonary procedure, a proximity detection tool during the pulmonary procedure, a 3D or 4D visualization view of the at least one or more portions of the patient, a heads-up display of the first layer input data, a heads-up display of at least one of the one or more patient sensor data, a heads-up display of at least one of the one or more patient imaging data, a heads-up display of physiological data of the patient, or a heads-up display of procedure-related data of the patient.
14. (Original) The method of claim 1, wherein the method is performed without use of fluoroscopy.
14. (Original) The method of claim 1, wherein the method is performed without use of fluoroscopy.
18. (Previously Presented) An apparatus, comprising: at least one processor; and a non-transitory computer readable medium communicatively coupled to the at least one processor, the non-transitory computer readable medium having stored thereon computer software comprising a set of instructions that, when executed by the at least one processor, causes the apparatus to:
receive one or more first layer input data from one or more first devices, the one or more first layer input data comprising data indicative of at least one of movement, position, or relative distance for one or more persons other than a patient and one or more objects within a room;
receive one or more second layer input data from one or more second devices, the one or more second layer input data comprising at least one of (1) one or more patient sensor data for monitoring procedure-relevant aspects of a patient or (2) one or more patient imaging data for monitoring images of one or more portions of a body of the patient;
analyze the received one or more first layer input data and the received one or more second layer input;
generate one or more recommendations for guiding a medical professional in navigating one or more surgical devices toward, around, through, and/or within one or more soft tissue luminal portions of the patient to perform a soft tissue luminal procedure, based at least in part on the analysis,
the generated one or more recommendations comprising at least one multi-dimensional mapped guide toward, in, and/or around the one or more soft tissue luminal portions of the patient,
generate one or more image-based outputs, the one or more image-based outputs comprising the multi-dimensional mapped guide; and present, using a user experience ("UX") device, the generated one or more image- based outputs.
17. (Currently Amended) An apparatus, comprising: at least one processor; and a non-transitory computer readable medium communicatively coupled to the at least one processor, the non-transitory computer readable medium having stored thereon computer software comprising a set of instructions that, when executed by the at least one processor, causes the apparatus to:
receive one or more first layer input data for an artificial intelligence algorithm from one or more first devices, the one or more first layer input data comprising at least one of movement data, position data, relative distance data, or externally observable data for each of one or more persons and one or more objects within a room;
receive one or more second layer input data for the artificial intelligence algorithm from one or more second devices, the one or more second layer input data comprising at least one of one or more patient sensor data for monitoring procedure-relevant aspects of a patient, one or more patient imaging data for monitoring images of one or more portions of a body of the patient, or one or more navigation and mapping data for monitoring one or more surgical devices relative to the one or more portions of the body of the patient, the patient being within the room;
analyze the received one or more first layer input data and the received one or more second layer input data based on the artificial intelligence algorithm;
generate one or more recommendations for guiding a medical professional in guiding the one or more surgical devices toward and within a lung of the patient to perform a pulmonary procedure, based at least in part on the analysis,
the generated one or more recommendations comprising three-dimensional ("3D") or four-dimensional ("4D") mapped guides toward, in, and around the lung of the patient;
generate one or more extended reality ("XR") images, based at least in part on the generated one or more recommendations; and present, using a user experience ("UX") device, the generated one or more XR images.
17/974689 fails to teach that the one or more first layer input data is based on one or more images captured external to the patient wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices, the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions, and the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient.
However, Schotzko teaches a method of guiding an instrument and presenting the guidance process on a graphical user interface (GUI) (paragraph 33), paragraph 52 discloses providing a plan or map to guide a clinician including tracking of the surgical instrument within the body of the patient. Paragraph 33 indicates that the image data is a 3D image data and paragraph 68 indicates that 3D projections of the target zone within which treatment is implement is shown on the GUI; and fig. 3A and paragraph 57 demonstrate the trajectory of a medical instrument within the region of interest, that is the heart according to paragraph 37, as represented on the GUI, in 3D image data.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure 17/700622 such that the one or more first layer input data is based on one or more images captured external to the patient wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices, the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions, and the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient, as taught by Schotzko, as such modification would allow a more efficient way to guide medical device to a targeted tissue area for medical treatment (paragraphs 4-6).
19. (Previously Presented) A system, comprising: a computing system, comprising: at least one first processor; and a first non-transitory computer readable medium communicatively coupled to the at least one first processor, the first non-transitory computer readable medium having stored thereon computer software comprising a first set of instructions that, when executed by the at least one first processor, causes the computing system to:
receive one or more first layer input data from one or more first devices, the one or more first layer input data comprising data indicative of at least one of movement, position, or relative distance for one or more persons other than a patient and one or more objects within a room;
receive one or more second layer input data from one or more second devices, the one or more second layer input data comprising at least one of (1) one or more patient sensor data for monitoring procedure- relevant aspects of a patient or (2) one or more patient imaging data for monitoring images of one or more portions of a body of the patient;
analyze the received one or more first layer input data and the received one or more second layer input;
generate one or more recommendations for guiding a medical professional in navigating one or more surgical devices toward, around, through, and/or within one or more soft tissue luminal portions of the patient to perform a soft tissue luminal procedure, based at least in part on the analysis,
the generated one or more recommendations comprising at least one multi-dimensional mapped guide toward, in, and/or around the one or more soft tissue luminal portions of the patient,
generate one or more image-based outputs, the one or more image-based outputs comprising the multi-dimensional mapped guide; and present, using a user experience ("UX") device, the generated one or more image-based outputs.
18. (Currently Amended) A system, comprising: a computing system, comprising: at least one first processor; and a first non-transitory computer readable medium communicatively coupled to the at least one first processor, the first non-transitory computer readable medium having stored thereon computer software comprising a first set of instructions that, when executed by the at least one first processor, causes the computing system to:
receive first layer input data for an artificial intelligence algorithm from one or more first devices, the first layer input data comprising at least one of movement data, position data, relative distance data, or externally observable data for each of one or more persons and one or more objects within a room;
receive second layer input data for an artificial intelligence algorithm from one or more second devices, the second layer input data comprising at least one of one or more patient sensor data for monitoring procedure-relevant aspects of a patient, one or more patient imaging data for monitoring images of one or more portions of a body of the patient, or one or more navigation and mapping data for monitoring one or more surgical devices relative to the one or more portions of the body of the patient;
analyze the received one or more first layer input data and the received one or more second layer input data based on the artificial intelligence algorithm;
generate one or more recommendations for guiding a medical professional in guiding the one or more surgical devices toward and within a lung of the patient to perform a pulmonary procedure, based at least in part on the analysis,
the generated one or more recommendations comprising three-dimensional ("3D") or four-dimensional ("4D") mapped guides toward, in, and around the lung of the patient;
generate one or more extended reality ("XR") images, based at least in part on the generated one or more recommendations; and present, using a user experience ("UX") device, the generated one or more XR images.
17974689 fails to teach that the one or more first layer input data is based on one or more images captured external to the patient wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices, the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions, and the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient;
However, Schotzko teaches a method of guiding an instrument and presenting the guidance process on a graphical user interface (GUI) (paragraph 33), paragraph 52 discloses providing a plan or map to guide a clinician including tracking of the surgical instrument within the body of the patient. Paragraph 33 indicates that the image data is a 3D image data and paragraph 68 indicates that 3D projections of the target zone within which treatment is implement is shown on the GUI; and fig. 3A and paragraph 57 demonstrate the trajectory of a medical instrument within the region of interest, that is the heart according to paragraph 37, as represented on the GUI, in 3D image data.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure 17/700622 such that the one or more first layer input data is based on one or more images captured external to the patient wherein: the multi-dimensional mapped guide includes a graphical element representing a target, a trajectory, or both a target and a trajectory, for navigating the one or more surgical devices, the multi-dimensional mapped guide comprises data corresponding to three dimensions, four dimensions, or more than four dimensions, and the one or more soft tissue luminal portions comprise at least one of a heart, a lung, a blood vessel, a gastrointestinal ("GI") tract, or another lumen of the patient, as taught by Schotzko, as such modification would allow a more efficient way to guide medical device to a targeted tissue area for medical treatment (paragraphs 4-6).
Conclusion
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/FAROUK A BRUCE/ Examiner, Art Unit 3797
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