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 .
Status of Claims
This is in response to applicant’s filing date of December 14, 2024. Claims 1-16 are currently pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 22, 2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Regarding U.S. Provisional Patent Application Nos. 63/610230, filed December 14, 2023, Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120 is acknowledged.
Claim Rejections --35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Polchin et al (US-20230390021-A1)(“Polchin”).
As per claim 1, Polchin discloses a method for controlling a robotic element in a surgical region based on imaging transformation (Figure 10), comprising:
establishing a frame of reference of a surgical target (Polchin at Para. [0003] discloses the frame of reference of the target or patient:” reference frame of this target is known as the patient reference frame. Such a term refers to the target itself since mathematically the reference frame of the securing device is defined by and identical to the reference frame of the target.”);
receiving an initial position reference indicative of a position of the surgical target from a surgical imaging modality within the frame of reference (Polchin at Figure 1C and Para. [0008] disclosing an initial position within the frame of reference:” system to determine the pose of patient anatomy (and hence the pose of patient volume scan data taken at or before this time) relative to the patient reference frame.”);
actuating a robotic instrument based on the position of the surgical target in the frame of reference (Polchin at Para. [0465] disclosing the movement and registration of the robot arm within a frame of reference:” robotic arm 120 can be moved at will because the navigation system of the EPU 160 updates the overlay correctly over the live view (to within the accuracy of the registration and the system 101 at large) as the robotic arm 120, and hence the camera pose moves relative to the patient anatomy. In some aspects, the system 101 may be used at one robot position, which may produce desirable results since movement of any part of the system 101 can cause the probability of registration degradation to increase.”);
receiving a subsequent position reference within the frame of reference (Polchin at Para. [0439] discloses maintaining a tracking of movement of the patient target frame and instruments:” the EPU 160 calculates the positional delta (as well as an extra orientational movement heuristic to be described) calculates between the navigated surgical marking pen tip 3012 and the patient reference frame. An optional “swivel” (i.e. angular movement of the marking pen body about its tip while the tip is held in place at the desired marking position) is detected by adding a “rotational delta threshold” to the “positional delta threshold” method. In this manner, the system 101 is configured to determine when the operator places and holds for some predetermined amount of time the tip 3012 of the navigated surgical marking pen 3002 onto some surface, which surface is presumed to be located on the patient anatomy.”); and
repositioning the robotic instrument based on an intraoperative modality analysis (Polchin at Para. [0094] discloses acquiring imaging data at different stages of a surgical plan:” pose of the patient anatomy in the preoperative, perioperative and/or intraoperative (typically 3d) patient data scan relative to the target(s') reference frame(s) on the fixed rigid structure (e.g., clamp) may be determined (step 112C).”) of the subsequent position reference with the position reference (Polchin at Para. [0464] discloses correcting any calculated misalignment between the target and the instruments:” misalignment such as movement of the patient anatomy in its securing device 240 or movement of the navigation target 230 on the securing device 240 can now be detected by the EPU 160 using the current virtual mark set and comparing it to the real marks in the live view. Such misalignment can now be corrected by adjusting the overlay as will be described. Note that misalignment correction is optimized for this stage of the surgical procedure. As the procedure progresses and real marks altered, removed or destroyed, the ability to correct misalignment degrades for this mark set.”).
As per claim 2, Polchin discloses a method of claim 1 further comprising:
establishing the frame of reference using a base imaging modality applied to a surgical region of a patient (Polchin at Para. [0004] discloses the use of a camera for the initial reference frame:” navigation camera is positioned to view the patient reference frame navigation target and the microscope/camera navigation target. It is understood that any other navigation targets to be used during the procedure (such as those attached to tools) must be brought into the field of view of the navigation camera during use.”); and
registering the position reference with the surgical imaging modality within the frame of reference of the base imaging modality (Polchin at Para. [0008] discloses registering the frame reference position:” Prior camera calibration and optical axis pose determination relative to the microscope-mounted navigation target enable the drawing and registered overlay of a representation of patient volume data”.), the base imaging modality being a different imaging modality than the surgical imaging modality defining the position and the subsequent position reference (Polchin at Para. [0008] discloses that the base modality is different than the initial camera data:” patient volume data, where the patient data is generated via one or more of several means such as pre-operative CT scan or MRI scan, or peri-operative such scans.”).
As per claim 3, Polchin discloses a method of claim 2 wherein the base imaging modality is one of CT (computed tomography) or MRI (magnetic resonance imaging) and the surgical imaging modality is one of a US (ultrasound) or PA (photoacoustic) (Polchin at Para. [0014] discloses use of CT scan and MRI:” the patient volume space includes patient volume scan data from magnetic resonance imaging (“MRI”) images, diffusion tensor imaging (“DTI”) images, or computed tomography (“CT”) images or a surgical template.”).
As per claim 4, Polchin discloses a method of claim 1 further comprising:
establishing the frame of reference from an imaging of a surgical region by a base imaging modality (Polchin at Para. [0061] discloses establishing a reference frame based on the surgical region:” recording of a patient registration in the form or real, physical marks or other such fiducials directly on the patient anatomy, which are correlated to virtual marks that are added to patient volume (scan) data or pre-operative surgical templates.”);
determining a position of the surgical target based on a frame of reference of the base imaging modality (Polchin at Para. [0419] discloses tracking the surgical target:” first trackable target 3006 enables the surgical navigation and visualization system 101 to determine a position and/or orientation (e.g., a pose) of the surgical marking pen 3002. The second trackable target 3008 enables the surgical navigation and visualization system 101 to determine a position and/or orientation (e.g., a pose) of the marking pen registration plate 3004.”); and
transforming the position of the surgical target to the frame of reference of the surgical imaging modality (Polchin at Para. [0419] discloses transforming the position data:” surgical navigation and visualization system 101 uses known poses to determine a position and/or transformation between the surgical marking pen 3002 and the marking pen registration plate 3004.”).
As per claim 5, Polchin discloses a method of claim 2 further comprising:
identifying the position of the surgical target within the frame of reference (Polchin at Para. [0419] discloses identifying position of the target based on surgical markings:” first trackable target 3006 enables the surgical navigation and visualization system 101 to determine a position and/or orientation (e.g., a pose) of the surgical marking pen 3002. The second trackable target 3008 enables the surgical navigation and visualization system 101 to determine a position and/or orientation (e.g., a pose) of the marking pen registration plate 3004.;
receiving a dense scan of a surgical region including the surgical target from the surgical imaging modality (Polchin at Para. [0421] discloses registering the position with scan data which using the broadest reasonable interpretation is dense scan since it pertains to bone scan data:” virtual location is stored in conjunction with patient volume scan data and/or surgical templates for subsequent registration correction.”);
registering the dense scan with the frame of reference established by the base imaging modality (Polchin at Para. [0454] discloses registering the scan data:” EPU 160 is configured to provide a registered overlay of the patient volume data over the live view. A planning phase built into the navigation software of the EPU 160 provides options to segment anatomical features such as bone from the rest of the patient data.”).
As per claim 6, Polchin discloses a method of claim 2 wherein the base imaging modality is a 3 dimensional medium and the surgical imaging modality returns a two dimensional representation of the surgical region (Polchin at Para. [0485] the use of 3D and 2D data in the different modalities:” a calibrated DSM head 110 is used. In such aspects, stereoscopic 3D images may be more accurate than 2D images and non-calibrated. In other aspects, stereoscopic 2D images and/or non-calibrated images may be used.”).
As per claim 7, Polchin discloses a method of claim 6 further comprising reconstructing the two dimensional representation for computing the position reference for the surgical target in the frame of reference (Polchin at Para. [0361] discloses rendering the 2D scan:” a 2D slice can be rendered at various levels along the optical axis relative to the focal point such that the surgeon can have a clear look at what is inside the patient.”).
As per claim 8, Polchin discloses a method of claim 1 wherein the position of the surgical target based successive position reference is indicative of a different position than the initial position reference (Polchin at Para. [0067] discloses determine successive position reference to identify misalignment due to movement of the target:” integrated surgical navigation and visualization system compares the virtual marks to the drawn physical marks or natural patient marks to determine if there is misalignment between the patient anatomy shown in the live view and the virtual marks.”).
As per claim 9, Polchin discloses a method of claim 1 further comprising: receiving a series of subsequent position references, each of the subsequent position references indicative of a different position of the surgical target (Polchin at Figure 14, procedure 3500, and Para. [0495] determining position changes to issue a command to move the robotic arm to correct the determined difference:” the EPU 160 is configured to use the calculated distances to determine pose adjustments to the robotic arm and/or the DSM head 110 to cause the virtual and physical marks to align. The EPU 160 then transmits instructions to the joint motors of the robotic arm 120 to move to the specified position/orientation and/or instructions to the DSM head 110 to proceed to certain optical properties, such as a zoom level or focal depth. In some embodiments, the EPU 160 moves the robotic arm 120 and/or adjusts the DSM head 110 iteratively. In these embodiments, the EPU 160 uses subsequent images to calculate new distances between the physical and virtual marks, and uses these new distances to determine further pose adjustments.”).
As per claim 10, Polchin discloses a method of claim 2 further comprising registering the position reference of the surgical imaging modality with the base imaging modality based on imaged features common to both the base imaging modality and the surgical imaging modality (Polchin at Figure 14, procedure 3500 and 3508, and Para. [0454] discloses registering position data over an overlay of the live surgery:” EPU 160 is configured to provide a registered overlay of the patient volume data over the live view. A planning phase built into the navigation software of the EPU 160 provides options to segment anatomical features such as bone from the rest of the patient data.”) .
As per claim 11, Polchin discloses a method of claim 2 further comprising registering the position reference of the surgical imaging modality with the base imaging modality based on an inserted fiducial common to both the base imaging modality and the surgical imaging modality (Polchin at Para. [0061] disclosing that fiducial markings are common to both base and surgical imaging modality:” a surgical marking pen, system (integrated surgical navigation and visualization system), and method that enable the recording of a patient registration in the form or real, physical marks or other such fiducials directly on the patient anatomy, which are correlated to virtual marks that are added to patient volume (scan) data or pre-operative surgical templates. The provided surgical marking pen may help enable correction of misalignment (patient degradation) due to patient draping, which is a major source of patient registration error.”).
As per claim 12, Polchin discloses a method of claim 2 further comprising employing an RGB-D camera for external positioning of the actuator in the surgical region (Polchin at Para. [0095] discloses a camera with distance and color viewing since colored lights are used for indicating a target reference on a patient:” the pose of the DSM camera relative to the navigation targets may be determined (e.g., in real time or near-real-time). For example, the navigation component of the integrated surgical navigation and visualization system may be used to view the targets on the clamp in real-time or near real-time to provide the latest pose of the digital surgical microscope camera(s) relative to the navigation targets. Thus, using data collected in the previous steps, the pose of the digital surgical microscope camera(s) relative to the patient data may be calculated.”) ; and registering the RGB-D camera with the frame of reference (Polchin at Para. [0009] discloses registering the patient data as acquired with the camera:” images of a live view of patient anatomy. The disclosed system registers patient data (e.g., patient volume scan data f) to the live images. The system then overlays the registered patient data on the live surgical view to provide computed assisted surgery.”).
As per claim 12, Polchin discloses a system for controlling a robotic element in a surgical region based on imaging transformation (Figure 2), comprising:
a base imaging modality configured for establishing a frame of reference of a surgical target (Polchin at Para. [0003] discloses the frame of reference of the target or patient:” reference frame of this target is known as the patient reference frame. Such a term refers to the target itself since mathematically the reference frame of the securing device is defined by and identical to the reference frame of the target.”);
an image server receiving an initial position reference indicative of a position of the surgical target from a surgical imaging modality within the frame of reference (Polchin at Para. [0069] discloses a remote and separate navigation system which under broadest interpretation is a server:” FIGS. 1A and 1B, the example surgical environment 100B of the present disclosure includes the integrated surgical navigation and visualization system 101C, whereas the environment 100A typically includes a surgical navigation system 101A separate and distinct from the surgical visualization system 101B.”);
a robotic instrument configured for actuation based on the position of the surgical target in the frame of reference (Polchin at Para. [0465] disclosing the movement and registration of the robot arm within a frame of reference:” robotic arm 120 can be moved at will because the navigation system of the EPU 160 updates the overlay correctly over the live view (to within the accuracy of the registration and the system 101 at large) as the robotic arm 120, and hence the camera pose moves relative to the patient anatomy. In some aspects, the system 101 may be used at one robot position, which may produce desirable results since movement of any part of the system 101 can cause the probability of registration degradation to increase.”), and a probe responsive to the surgical imaging modality for receiving a subsequent position reference within the frame of reference (Polchin at Figure 1C and Para. [0008] disclosing an initial position within the frame of reference:” system to determine the pose of patient anatomy (and hence the pose of patient volume scan data taken at or before this time) relative to the patient reference frame.”), the robotic instrument configured for repositioning the robotic instrument based on an intraoperative modality analysis of the subsequent position reference with the position reference (Polchin at Para. [0094] discloses acquiring imaging data at different stages of a surgical plan:” pose of the patient anatomy in the preoperative, perioperative and/or intraoperative (typically 3d) patient data scan relative to the target(s') reference frame(s) on the fixed rigid structure (e.g., clamp) may be determined (step 112C).”).
As per claim 14, Polchin discloses a system of claim 13 wherein the image server establishes the frame of reference using the base imaging modality applied to a surgical region of a patient (Polchin at Para. [0004] discloses the use of a camera for the initial reference frame:” navigation camera is positioned to view the patient reference frame navigation target and the microscope/camera navigation target. It is understood that any other navigation targets to be used during the procedure (such as those attached to tools) must be brought into the field of view of the navigation camera during use.”), and registering the position reference with the surgical imaging modality within the frame of reference of the base imaging modality (Polchin at Para. [0008] discloses registering the frame reference position:” Prior camera calibration and optical axis pose determination relative to the microscope-mounted navigation target enable the drawing and registered overlay of a representation of patient volume data”.), the base imaging modality being a different imaging modality than the surgical imaging modality defining the position and the subsequent position reference (Polchin at Para. [0008] discloses that the base modality is different than the initial camera data:” patient volume data, where the patient data is generated via one or more of several means such as pre-operative CT scan or MRI scan, or peri-operative such scans.”).
As per claim 15, Polchin discloses a system of claim 14 wherein the base imaging modality is one of CT (computed tomography) or MRI (magnetic resonance imaging) and the surgical imaging modality is one of a US (ultrasound) or PA (photoacoustic) (Polchin at Para. [0014] discloses use of CT scan and MRI:” the patient volume space includes patient volume scan data from magnetic resonance imaging (“MRI”) images, diffusion tensor imaging (“DTI”) images, or computed tomography (“CT”) images or a surgical template.”).
As per claim 16, Polchin discloses a computer program embodying program code on a non-transitory computer readable storage medium that, when executed by a processor, performs steps for implementing a method for method for controlling a robotic element in a surgical region based on imaging transformation (Figure 1, EPU 160), the method comprising:
establishing a frame of reference of a surgical target (Polchin at Para. [0003] discloses the frame of reference of the target or patient:” reference frame of this target is known as the patient reference frame. Such a term refers to the target itself since mathematically the reference frame of the securing device is defined by and identical to the reference frame of the target.”);
receiving an initial position reference indicative of a position of the surgical target from a surgical imaging modality within the frame of reference (Polchin at Figure 1C and Para. [0008] disclosing an initial position within the frame of reference:” system to determine the pose of patient anatomy (and hence the pose of patient volume scan data taken at or before this time) relative to the patient reference frame.”);
actuating a robotic instrument based on the position of the surgical target in the frame of reference (Polchin at Para. [0465] disclosing the movement and registration of the robot arm within a frame of reference:” robotic arm 120 can be moved at will because the navigation system of the EPU 160 updates the overlay correctly over the live view (to within the accuracy of the registration and the system 101 at large) as the robotic arm 120, and hence the camera pose moves relative to the patient anatomy. In some aspects, the system 101 may be used at one robot position, which may produce desirable results since movement of any part of the system 101 can cause the probability of registration degradation to increase.”);
receiving a subsequent position reference within the frame of reference (Polchin at Para. [0439] discloses maintaining a tracking of movement of the patient target frame and instruments:” the EPU 160 calculates the positional delta (as well as an extra orientational movement heuristic to be described) calculates between the navigated surgical marking pen tip 3012 and the patient reference frame. An optional “swivel” (i.e. angular movement of the marking pen body about its tip while the tip is held in place at the desired marking position) is detected by adding a “rotational delta threshold” to the “positional delta threshold” method. In this manner, the system 101 is configured to determine when the operator places and holds for some predetermined amount of time the tip 3012 of the navigated surgical marking pen 3002 onto some surface, which surface is presumed to be located on the patient anatomy.”); and
repositioning the robotic instrument based on an intraoperative modality analysis (Polchin at Para. [0094] discloses acquiring imaging data at different stages of a surgical plan:” pose of the patient anatomy in the preoperative, perioperative and/or intraoperative (typically 3d) patient data scan relative to the target(s') reference frame(s) on the fixed rigid structure (e.g., clamp) may be determined (step 112C).”) of the subsequent position reference with the position reference (Polchin at Para. [0464] discloses correcting any calculated misalignment between the target and the instruments:” misalignment such as movement of the patient anatomy in its securing device 240 or movement of the navigation target 230 on the securing device 240 can now be detected by the EPU 160 using the current virtual mark set and comparing it to the real marks in the live view. Such misalignment can now be corrected by adjusting the overlay as will be described. Note that misalignment correction is optimized for this stage of the surgical procedure. As the procedure progresses and real marks altered, removed or destroyed, the ability to correct misalignment degrades for this mark set.”).
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Layer, James H. (US-20030208207-A1) Apparatus for positioning a medical instrument relative to a patient;
SHOHAM; Moshe (US-20170055940-A1) ULTRASOUND GUIDED HAND HELD ROBOT;
Stern; John D. et al. (US-20070083098-A1) Autofocus and/or autoscaling in telesurgery;
Braido; Peter N. et al. (US-20230157762-A1) Extended Intelligence Ecosystem for Soft Tissue Luminal Applications;
DiMaio; Simon P. et al. (US-20200360097-A1) MASTER/SLAVE REGISTRATION AND CONTROL FOR TELEOPERATION;
TADANO; Kotaro et al. (US-20220409311-A1) SURGICAL ROBOT;
Shahidi; Ramin (US-20070225553-A1) Systems and Methods for Intraoperative Targeting;
KUO; Yu-Ching Audrey et al. (US-20180235714-A1) METHOD, SYSTEM AND APPARATUS FOR MAINTAINING PATIENT REGISTRATION IN A SURGICAL NAVIGATION SYSTEM;
Crawford; Neil R. et al. (US-20130345718-A1) SURGICAL ROBOT PLATFORM.
Abbasi; Abdullah et al. (US-20220133419-A1) ROBOTIC SURGICAL SYSTEM WITH RECOVERY ALIGNMENT;
ARAI; Jun et al. (US-20190328475-A1) MEDICAL SUPPORT ARM APPARATUS;
Panescu; Dorin et al. (US-20140343416-A1) SYSTEMS AND METHODS FOR ROBOTIC MEDICAL SYSTEM INTEGRATION WITH EXTERNAL IMAGING;
Boctor; Emad M. et al. (US-20150031990-A1) PHOTOACOUSTIC TRACKING AND REGISTRATION IN INTERVENTIONAL ULTRASOUND;
Mak; Siu Wai Jacky et al. (US-20220015636-A1) METHOD, SYSTEM AND APPARATUS FOR TRACKING SURGICAL IMAGING DEVICES;
Reimer; Brendan et al. (US-20230181263-A1) DYNAMIC 3D SCANNING ROBOTIC LAPAROSCOPE.
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/ELLIS B. RAMIREZ/Examiner, Art Unit 3658
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