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 .
Status of Claims
This Office Action is responsive to the claims filed on 05/28/2026. Claims 1, 2, 6, 11, 12, 14, and 16 have been amended. Claims 1-20 are presently pending in this application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 5, 11, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Carcieri-129 (WO 2016019129 A1) in view of Pathak (US 20220202491 A1), Hendricks (US 20240165419) and Carcieri-081 (WO 2014036081 A1).
Regarding claims 1 and 11, Carcieri-129 teaches a system and a method (Paragraphs [12]-[14]; system and methods to manage data; data may pertain to, for example, stimulation of a patient for deep brain stimulation) of evaluating an input regarding a procedure and an outcome (Paragraph [13]; It may include target volumes selected for a patient, and/or volumes of estimated activation (VOA) for various stimulation parameters input for the patient. It may include information concerning how close the patient's anatomical images match to a standard atlas);
the system comprising a navigation system (Paragraph [66]-[67]; MR or CT system used to store lead location) configured to receive a plurality of signals (Paragraph [66]-[68]; the detailed computations - fusion of MR/CT, fusion of atlas to MR, lead location, VOA generation, etc. can be performed at a server and the resulting information can be stored centrally; Paragraph [259]; a large database of lead contact positions, stimulus parameters, and outcomes are obtained and the system performs a machine learning exercise to model the dependence of stimulus parameters on the outcomes and the contact positions),
and a processor module (Paragraph [30]-[31] and [261]; computer processor) a processor module configured to execute instructions to (Paragraph [261]; methods disclosed herein can be implemented by computer program instructions. These program instructions may be provided to a processor such that the instructions, which execute on the processor, create means for implementing the actions) perform the method comprising:
receiving a plurality of signals associated with a current subject (Paragraph [66]-[68]; the detailed computations - fusion of MR/CT, fusion of atlas to MR, lead location, VOA generation, etc. can be performed at a server and the resulting information can be stored centrally; Paragraph [259]; a large database of lead contact positions, stimulus parameters, and outcomes are obtained and the system performs a machine learning exercise to model the dependence of stimulus parameters on the outcomes and the contact positions; Paragraph [86]; addition to fusing MR and CT datasets… to automatically or manually determine the positions of stimulation leads; The lead position and trajectories are obtained from MR/CT images which would include a position and orientation of the lead; Paragraph [82]; generating estimated volumes of activation… can obtain clinical effects data associated with the VOAs corresponding to the implemented stimulation programs; Paragraph [0119]; while a patient is stimulated by a set of stimulation settings, the system is configured to obtain information concerning the patient's condition, e.g., via patient input or by sensor signals, as described above. The information and settings can be time-stamped. The condition can include therapeutic effects, side effects, patient ratings, and the like, or any combination thereof);
agglomerating the received plurality of signals (Paragraph [212]; system includes features by which to collect VOA related data over time to then be subject to an analysis… compilation of a parameter set of an analysis to be conducted on an input set of data; Paragraph [259]; system performs a machine learning exercise to model the dependence of stimulus parameters on the outcomes and the contact positions);
receiving an outcome for each signal of the received plurality of signals (Paragraph [220]; provides for a cycle of testing stimulation settings that produce corresponding VOAs, obtaining results of such tested settings; Paragraph [259]; and outcomes are obtained);
evaluating the agglomerated received plurality of signals (Paragraph [150]-[153]; the system is configured to compare different groups of VOAs to determine target volumes of stimulation and/or volumes to be avoided; find an area included in the group associated with the side effect (or therapeutic effect)) to determine a correlation of a selected outcome to (i) the at least one tracked pose of the implant and (ii) the at least one volume of activation generated by the implant at the received tracked pose of the implant (Paragraph [155]-[157]; based on the VOAs of the patient population and their corresponding clinical effects, determine on a voxel-by-voxel basis; Paragraph [157]; with further information concerning the leadwire location, the system is configured to output the stimulation parameters for stimulating the thus generated target region or for avoiding the thus generated side effect region).
Carcieri-129 does not explicitly teach each of the signals relates to (i) at least one tracked pose of an implant and(ii) at least one volume of activation generated by the implant at the received tracked pose of the implant; and
receiving an outcome for each of the received signals of the plurality of signals that relates the at least one tracked pose of the implant to the at least one volume of activation generated by the implant at the received tracked pose;
receiving past outcomes associated with past subjects, the past outcomes linked to at least one past tracked pose of the implant to at least one past volume of activation generated by the implant at the past tracked pose corresponding to each of the one or more past subjects;
and evaluating the agglomerated received plurality of signals in combination with the received past outcomes.
and generating, based on the determined correlation and anatomical image data of the current subject, a recommended implant trajectory comprising an entry point and an insertion angle specific to the current subject.
Pathak teaches a method of evaluating an input regarding a procedure and an outcome (Paragraph [0006]; a computer-implemented method of electrode trajectory planning for DBS therapy is disclosed; Paragraph [0008]; after obtaining, identifying or otherwise predicting the structures of interest in the patient's brain image, an “electrode scene” may be built wherein a representation of a DBS electrode may be automatically generated relative to an optimal trajectory that targets the ROI), comprising:
receiving a plurality of signals associated with a current subject (Paragraph [0063]; an input MRI brain image of a patient 602 as described hereinabove; Paragraph [0068]; a functional MRI process may be performed in which stimuli is provided to the patient and the MRI imaging is utilized to identify the specific structures in the brain that respond to the stimuli), each of the signals relating to (i) at least one tracked pose of an implant (Paragraph [0063]; As the instrumentation is advanced, its trajectory may be monitored, e.g., based on tracking on prerecorded imaging or live imaging, via a display monitor 616) and (ii) at least one volume of activation generated by the implant (Paragraph [0068]; MRI imaging is utilized to identify the specific structures in the brain that respond to the stimuli; The specific structures identified responding to stimuli are considered to read on the claimed limitation of volume of activation generated by the implant as understood in its broadest reasonable interpretation) at a tracked pose of the implant (Paragraph [0063]; generate an optimal trajectory based on building a virtual electrode scene responsive to analyzing an input MRI brain image of a patient 602; As the instrumentation is advanced, its trajectory may be monitored, e.g., based on tracking on prerecorded imaging or live imaging, via a display monitor 616);
receiving past outcomes associated with one or more past subjects (Paragraph [0060]; training dataset may be a dataset of input images or slices (processed, preprocessed or unprocessed) used during the learning process of a CNN/ANN and is used to fit the parameters of the CNN/ANN), the past outcomes linked to at least one past tracked pose of the implant (Paragraph [0060]; obtain medical imaging data relating to human cranial anatomy from a number of public and/or private repositories 402-1 to 402-K containing image slices in various imaging modalities… a training/validation dataset 412 is exemplified as a labeled dataset that may be provided to a training process 416 with respect to training and validating an ML image classifier for predicting the ROI/ROA features in human brain scan images; Paragraph [0031]; facilitating ML-based image identification for identifying ROIs and ROAs in connection with electrode trajectory planning; Fig. 2 A; The ML trained dataset with ROI in connection with training the electrode trajectory planning is considered to read on the claimed limitation of the past outcomes linked to at least one past tracked pose of the implant as understood in its broadest reasonable interpretation);
generating, based on the determined correlation and anatomical image data of the current subject (Paragraph [0068]; Based upon the imaging information, the trained ML-based trajectory planning scheme may be executed to provide real time target location information and optimal path data to a stereotactic surgery system including the guiding apparatus as described), a recommended implant trajectory comprising an entry point (Paragraph [0043]; the trajectory data comprising the entry point coordinate set) and an insertion angle specific to the current subject (Paragraph [0068]; optimal path data to a stereotactic surgery system including the guiding apparatus, Paragraph [0063] and Fig. 6 show the translational/rotational movement of the servo motors 610 is included in the guiding which is considered to read on an insertion angle specific to the current subject as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system and method of Carceri-129 such that each of the signals relates to (i) at least one tracked pose of an implant and(ii) at least one volume of activation generated by the implant at the received tracked pose of the implant and generating, based on the determined correlation and anatomical image data of the current subject, a recommended implant trajectory comprising an entry point and an insertion angle specific to the current subject as taught by Pathak. Measuring signals with respect to the patient image data may allow selection of a trajectory for precise control of the stimulation pulses and avoiding the stimulation of undesired tissue (Paragraph [0067]). Further the generation of an entry point and an insertion angle specific to the current subject would allow for automatic guidance and performing of the surgery to place the electrode at the target position (Paragraph [0063]).
Together Carcieri-129 and Pathak do not explicitly teach receiving an outcome for each of the received signals of the plurality of signals that relates the at least one tracked pose of the implant to the at least one volume of activation generated by the implant at the received tracked pose;
receiving past outcomes associated with past subjects, the past outcomes linked to at least one past tracked pose of the implant to at least one past volume of activation generated by the implant at the past tracked pose corresponding to each of the one or more past subjects;
and evaluating the agglomerated received plurality of signals in combination with the received past outcomes.
Hendricks, however, teaches a method of evaluating an input regarding a procedure and an outcome (Paragraph [0024]; systems and methods for a computer-implemented electric field therapy (EFT) planning system that uses machine learning to guide and optimize a set of EFT treatment parameters based on patient imaging), comprising:
receiving a plurality of signals (Paragraph [0047]; the set of EFT treatment parameters including electrode configuration, a required resection region, and one or more stimulating parameters that dictate waveforms for application of EFT treatment; Paragraph [0092]; includes a stimulating parameter solver 172 that optimizes one or more stimulating parameters, such as waveform parameters, to be applied to the region of interest by modeling and optimizing the stimulating parameters and their estimated effect on tissue relative to the ROI object 250 with respect to the one or more modeled electrode objects 260), each of the signals relates to (i) at least one tracked pose of an implant (Paragraph [0048]; These can include electrode configuration parameters such as electrode position, electrode design, and electrode count) and (ii) at least one volume of activation generated by the implant (Paragraph [0032]; The set of EFT treatment parameters can include stimulating parameters to be applied to the tissue by the implantable EFT application system 20; Paragraph [0036]; Volume conductor modeling (VCM) permits the estimation of electric field distribution within finite-element modeled tissue… following the stimulation of tissue by implanted electrodes.) at the received tracked pose of the implant (Paragraph [0056]; and the stimulating parameters to be applied to the virtual space mesh model 240 by modeled electrode object 260 in order to identify the resultant total AOE region 270 for the set of EFT treatment parameters);
receiving an outcome for each of the received signals of the plurality of signals that relates the at least one tracked pose of the implant to the at least one volume of activation generated by the implant at the received tracked pose (Paragraph [0056]; Since the set of EFT treatment parameters are to be optimized by the EFT optimization system 140, the one or more simulation modules 192 can model the effects of the one or more electrodes 24 throughout tissue as the EFT optimization system 140 varies the set of EFT treatment parameters applied with the modeled electrode object 260 to identify the optimal set of EFT treatment parameters that result in the best modeled effects through the virtual space mesh model 240. In some embodiments, the optimal set of EFT treatment parameters result in a maximal resultant total AOE region 270 with respect to the ROI object 250 that meets the EFT coverage threshold of sufficient treatment while maintaining practitioner preferences (if one or more parameters are specified as “fixed constants” by the practitioner) and while not violating modeling rules (i.e., so as not to generate impossible configurations) or safety guidelines (i.e., applied stimulating parameter rules 195 or restricted areas rules 196); The results of the modeled effects are considered to be an outcome for each of the received signals of the plurality of signals that relates the at least one tracked pose of the implant to the at least one volume of activation as understood in its broadest reasonable interpretation);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system and method of Carcieri-129 in view of Pathak to include receiving an outcome for each of the received signals of the plurality of signals that relates the at least one tracked pose of the implant to the at least one volume of activation generated by the implant at the received tracked pose as taught by Hendricks. This would have enabled a practitioner to simulate and view the effects of various EFT treatment parameters of the set of EFT treatment parameters with respect to the 3-D virtual mesh model of patient anatomy and ensure properly planning the placement of the electrodes for treatment (Hendricks, paragraph [0026]). Furthermore, it would aid in determining the optimal electric field parameters to result in maximal coverage while not violating specific rules or safety guidelines (Paragraph [0056]).
Together Carcieri-129, Pathak, and Hendricks do not explicitly teach receiving past outcomes associated with past subjects, the past outcomes linked to at least one past tracked pose of the implant to at least one past volume of activation generated by the implant at the past tracked pose corresponding to each of the one or more past subjects;
and evaluating the agglomerated received plurality of signals in combination with the received past outcomes.
Carcieri-081, however, teaches receiving past outcomes associated with past subjects (Paragraph [122]; The clinical effects maps are based on the recorded information regarding a respective plurality of actual locations (e.g., voxels that have been part of one or more VOAs corresponding to historically conducted stimulations) for which clinical effect data has already been captured; Paragraph [137]; described maps are continuously updated as more data points are added so that the "fog" of unexplored areas of an anatomy of a… group of patients), the past outcomes linked to at least one past tracked pose of the implant (Paragraph [0105]; method outputs stimulation amplitude information in a three dimensional coordinate system in which each plotted data point is identified by a longitudinal position 'z', angle of rotation 'θ', and radius from center 'r'; Paragraph [132]; In FIG. 16 a rotationally asymmetrical leadwire 1200, i.e., including directional electrodes 1202, for which associated clinical effect values have been recorded is shown) to at least one past volume of activation generated by the implant at the past tracked pose corresponding to each of the one or more past subjects (Paragraph [122]; recorded information regarding a respective plurality of actual locations (e.g., voxels that have been part of one or more VOAs corresponding to historically conducted stimulations) for which clinical effect data has already been captured; Paragraph [124]; clinical effect values are assigned or determined for each voxel based on the collected data available from all available VOAs 1204 including therapeutic effect information for the respective voxel);
and evaluating the agglomerated received plurality of signals in combination with the received past outcomes (Paragraph [125]; for each new VOA, for each voxel of the VOA, the system compares the effect value for the current VOA to the effect value stored in association with the voxel, and updates the voxel value only if the new value is greater than the previously stored value… only minimum values are represented, for each new VOA, for each voxel of the VOA, the system compares the effect values for the current VOA to the effect value stored in association with the voxel, and updates the voxel value only if the new value is less than the previously stored value… other mathematical functions, e.g., an average, can be used to score a voxel, which may require retaining more, e.g., all, historical values for the voxel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method and system of Carcieri-129 in view of Pathak and Hendricks to have further included steps of receiving past outcomes associated with past subjects, the past outcomes linked to at least one past tracked pose of the implant to at least one past volume of activation generated by the implant at the past tracked pose corresponding to each of the one or more past subjects; and evaluating the agglomerated received plurality of signals in combination with the received past outcomes as taught by Carcieri-081 because it would have improved the ability to indicate the volumes one might expect to be required to be stimulated for achieving a certain level of therapeutic effect and further be used to depict independent graphical representations for therapeutic information and side effect information for the previously mapped voxels (Paragraph [131]). Furthermore, the described maps are continuously updated as more data points are added so that the "fog" of unexplored areas of an anatomy of a patient (or group of patients) can be removed to provide a clearer and more complete picture of the patient reactions to stimulation. Additionally, the maps can be updated over time to reflect changes in values with which voxels are associated (Paragraph [137]).
Regarding claims 2 and 12, together Carcieri-129, Pathak, Hendricks, and Carcieri-081 teach all of the limitations of claims 1 and 11 as noted above, respectively.
Carcieri-129 further teaches storing the determined correlation for recall to plan the current procedure (Paragraphs [220]-[225]; respective results of stimulations using such settings can be stored at a single location for access by one or more clinicians who can set new target volumes and/or choose modified target stimulation regions based on results of the analyses; Dr. A can save the target volume under any descriptive name by which Dr. A can later identify the target volume in a useful manner).
Regarding claims 5 and 15, together Carcieri-129, Pathak, Hendricks, and Carcieri-081 teach all of the limitations of claims 1 and 11 as noted above, respectively.
Carcieri-129 further teaches determining a volume of activation after implanting the implant (Paragraph [69]; stimulation programming module for programming the IPG to cause the implanted leadwire to generate electrical pulses according to the program; effects information are correlated with the stimulation program set in the programming module and for which the program planning module generates estimated VOAs); and
relating the volume of activation to the tracked pose of the implant (Paragraphs [86]; Registration module allows the user to automatically or manually determine the positions of stimulation leads… allows the user to visualize areas of the brain activated in response to different DBS stimulation settings);
wherein determining the correlation of the selected outcome is based at least on the related volume of activation (Paragraphs [155]; based on the VOAs of the patient population and their corresponding clinical effects, determine on a voxel-by-voxel basis, which voxels contribute to a certain effect, and combine those voxels into a target or side- effect volume).
Claims 3, 4, 6-10, 13, 14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Carcieri-129 in view of Pathak, Hendricks, and Carcieri-081 as applied to claims 1 and 11 above, respectively, and further in view of Tsay (US 20190240489).
Regarding claims 3 and 13, together Carcieri-129, Pathak, Hendricks, and Carcieri-081 teach all of the limitations of claims 1 and 11 as noted above, respectively.
Together Carcieri-129, Pathak, Hendricks, and Carcieri-081 do not explicitly teach providing an implant tracking device associated with the implant; and tracking a pose of the implant with the implant tracking device.
Tsay, however, teaches a method and system for implanting an electrode (Paragraph [0007]; provide navigation for tracking an instrument… instrument may be an instrument to assist in a procedure and/or may be a permanently implanted device) comprising receiving a plurality of signals (Paragraph [0038]; transmit signals from the tracking device 70) that relates to at least one of (i) at least one tracked pose of an implant (Paragraph [0052]; navigation system 20 may allow for tracking of selected portions of the cochlear implant 226… configured to allow for a determination of six degree of freedom position (including location and orientation)) or (ii) at least one volume of activation generated by the implant at the received tracked pose (Paragraph [0084] and [0089]; pairwise capacitance between all of the electrodes relative to each of the other electrodes may be made in block 368; Measured capacitance may be based upon an applied voltage on the implantable device 226 between the various electrodes and the implantation system); and
providing an implant tracking device associated with the implant (Paragraph [0028]; electropotential (EP) tracking system 22 and an electromagnetic (EM) tracking system 24 can be used to track one or more instruments… such as a lead used as a part of an implantable medical device (IMD)); and
and tracking a pose of the implant with the implant tracking device (Paragraph [0055]-[0057]; signal from the tracking device 250 is used to determine the position, including three-dimensional location and one or more orientation in the space of the tracking device 250 therefore, the instrument; can be used to show or determine a specific position of a plurality of points along the length of the body 230).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method and system of Carcieri-129 in view of Pathak, Hendricks and Carcieri-081 to have included providing an implant tracking device associated with the implant; and tracking a pose of the implant with the implant tracking device as taught by Tsay because it would have allowed optimization of electrode positions and shape during the procedure (Tsay, paragraph [0098] and [0129]) which would have reduced the procedure times and improved the efficacy of the procedure by ensuring the electrodes are placed properly.
Regarding claims 4 and 14, together Carcieri-129, Pathak, Hendricks, Carcieri-081, and Tsay teach all of the limitations of claim 3 and 13 as noted above, respectively.
Tsay further teaches receiving the plurality of signals is based on tracking the implant (Paragraph [0038]; transmit signals from the tracking device 70; Paragraph [0055]-[0057]; signal from the tracking device 250 is used to determine the position, including three-dimensional location and one or more orientation in the space of the tracking device 250 therefore, the instrument).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the method and system of Carcieri-129 in view of Pathak, Hendricks, Carcieri-081, and Tsay to have included receiving the plurality of signals is based on tracking the implant as taught by Tsay because it would allow determination of the final location and when a selected location has been achieved of the implant (Tsay, Paragraph [0057]) and further ensure the method of planning future implants is based on an accurate final location and determined electrode positions, thereby improving the planning accuracy in the final system and method of Carcieri-129 in view of Tsay.
Regarding claims 6 and 16, together Carcieri-129, Pathak, Hendricks, and Carcieri-081 teaches all of the limitations of claims 1 and 11 as noted above, respectively.
Together Carcieri-129, Pathak, Hendricks, and Carcieri-081 does not explicitly teach tracking the implant with an implant tracking device;
determining the tracked pose based on the tracking the implant tracking device at a final implant pose;
wherein the received plurality of signals is based on the tracking of the implant tracking device at the final implant pose.
Tsay, however, teaches a method and system for implanting an electrode (Paragraph [0007]; provide navigation for tracking an instrument… instrument may be an instrument to assist in a procedure and/or may be a permanently implanted device) comprising receiving a plurality of signals (Paragraph [0038]; transmit signals from the tracking device 70) that relates to at least one of (i) at least one tracked pose of an implant (Paragraph [0052]; navigation system 20 may allow for tracking of selected portions of the cochlear implant 226… configured to allow for a determination of six degree of freedom position (including location and orientation)) or (ii) at least one volume of activation generated by the implant at the received tracked pose (Paragraph [0084] and [0089]; pairwise capacitance between all of the electrodes relative to each of the other electrodes may be made in block 368; Measured capacitance may be based upon an applied voltage on the implantable device 226 between the various electrodes and the implantation system); and
tracking the implant (Paragraph [0055]-[0057]; signal from the tracking device 250 is used to determine the position, including three-dimensional location and one or more orientation in the space of the tracking device 250 therefore, the instrument; can be used to show or determine a specific position of a plurality of points along the length of the body 230) with an implant tracking device (Paragraph [0028]; electropotential (EP) tracking system 22 and an electromagnetic (EM) tracking system 24 can be used to track one or more instruments… such as a lead used as a part of an implantable medical device (IMD));
determining the tracked pose based on tracking the implant tracking device (Paragraph [0055]-[0057]; signal from the tracking device 250 is used to determine the position, including three-dimensional location and one or more orientation in the space of the tracking device 250 therefore, the instrument) at a final implant pose (Paragraph [0057]; determine the final location and when a selected location has been achieved of the implant 226; Paragraph [0104]; determined shape and position of the implantable device… is properly located in a selected or final location.);
wherein the received plurality of signals are based on the tracking of the implant tracking device at the final implant pose (Paragraph [0104]; as the tracked location of the tracking device 250 is known relative to the image 40 and the shape is determined relative to the tracking device 250 the determined shape of the implantable device 226 may be displayed; The received signal from the tracking device is used to determine the final shape and position of the implantable device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the method and system of Carcieri-129 in view of Pathak, Hendricks and Carcieri-081 to have included tracking the implant with an implant tracking device; and determining the tracked pose based on the tracking the implant tracking device at the final implant pose; wherein the received signal is based on the tracking of the implant tracking device at the final implant pose as taught by Tsay. This would have allowed determination of the final location and when a selected location has been achieved of the implant (Tsay, Paragraph [0057]) and allowed optimization of electrode positions and shape during the procedure (Tsay, paragraph [0098] and [0129]) which would have reduced the procedure times and improved the efficacy of the procedure by ensuring the electrodes are placed properly.
Regarding claim 7, together Carcieri-129, Pathak, Hendricks, and Carcieri-081, teach all of the limitations of claim 6 as noted above.
Carcieri-129 further teaches storing the final implant pose (Paragraph [67]; the central server… could store the location of the lead in the resulting patient-specific atlas).
Regarding claim 8, together Carcieri-129, Pathak, Hendricks, and Carcieri-081 teach all of the limitations of claims 1 as noted above, respectively.
Carcieri-129 further teaches storing the final implant pose (Paragraph [67]; the central server… could store the location of the lead in the resulting patient-specific atlas); and
operating a processor module to evaluate the agglomerated received plurality of signals to determine the correlation of the selected outcome (Paragraph [150]-[153]; the system is configured to compare different groups of VOAs to determine target volumes of stimulation and/or volumes to be avoided; find an area included in the group associated with the side effect (or therapeutic effect)).
Together Carcieri-129, Hendricks, and Carcieri-081 does not explicitly teach determining the tracked pose of the implant with a tracking system;
storing the determined tracked pose with the tracking system;
operating a processor module of the tracking system.
Tsay, however, teaches a method and system for implanting an electrode (Paragraph [0007]; provide navigation for tracking an instrument… instrument may be an instrument to assist in a procedure and/or may be a permanently implanted device) comprising receiving a plurality of signals (Paragraph [0038]; transmit signals from the tracking device 70) that relates to at least one of (i) at least one tracked pose of an implant (Paragraph [0052]; navigation system 20 may allow for tracking of selected portions of the cochlear implant 226… configured to allow for a determination of six degree of freedom position (including location and orientation)) or (ii) at least one volume of activation generated by the implant at the received tracked pose (Paragraph [0084] and [0089]; pairwise capacitance between all of the electrodes relative to each of the other electrodes may be made in block 368; Measured capacitance may be based upon an applied voltage on the implantable device 226 between the various electrodes and the implantation system); and
determining the tracked pose of the implant (Paragraph [0055]-[0057]; signal from the tracking device 250 is used to determine the position, including three-dimensional location and one or more orientation in the space of the tracking device 250 therefore, the instrument; can be used to show or determine a specific position of a plurality of points along the length of the body 230) with a tracking system (Paragraph [0028]; electropotential (EP) tracking system 22 and an electromagnetic (EM) tracking system 24 can be used to track one or more instruments… such as a lead used as a part of an implantable medical device (IMD); paragraph [0032]-[0033]; The navigation system 20, also including the tracking systems 22, 24 can be incorporated or connected to the processor system 44);
storing the determined tracked pose with the tracking system (Paragraph [0042]; The image data and atlas data may be stored or recalled from the memory 44b; memory 44b is part of processor system 44 which includes the tracking system 22, 24, Fig. 1);
operating a processor module of the tracking system (paragraph [0032]-[0033]; The navigation system 20, also including the tracking systems 22, 24 can be incorporated or connected to the processor system 44; Paragraph [0096]; pairwise capacitance may be performed by a processor system, such as the processor system 44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Carcieri-129 in view of Pathak, Hendricks and Carcieri-081 to have included determining the tracked pose of the implant with a tracking system; storing the determined tracked pose with the tracking system; operating a processor module of the tracking system. Determining the tracked pose of the implant with a tracking system would have allowed optimization of electrode positions and shape during the procedure (Tsay, paragraph [0098] and [0129]) which would have reduced the procedure times and improved the efficacy of the procedure by ensuring the electrodes are placed properly. Furthermore, storing the determined tracked pose with the tracking system, receiving the outcome with the tracking system; and operating a processor module of the tracking system would have been a mere rearrangement of steps of moving the processing steps performed by the system of Carcieri-129 in view of Hendricks to the combined system of Carcieri-129 in view of Hendricks and Tsay which includes the tracking system. It would further improve the method by allowing the system to be able to directly access tracking and outcomes from the operation, thereby improving the overall computations.
Regarding claim 9, together Carcieri-129, Pathak, Hendricks, Carcieri-081, and Tsay teach all of the limitations of claim 8 as noted above. Carcieri-129 further teaches the outcome is classified into at least a first outcome and a second outcome (Paragraph [119]; The condition can include therapeutic effects, side effects);
wherein the determined correlation includes a relationship between at least the tracked pose and the first outcome or the second outcome (Paragraph [152]; configured to transform the VOAs to a single common atlas space and find an area included in the group associated with the side effect (or therapeutic effect)).
Regarding claim 10, together Carcieri-129, Pathak, Hendricks, Carcieri-081, and Tsay teach all of the limitations of claim 8 as noted above.
Tsay further teaches displaying the determined tracked pose of the implant with a display device relative to an image of a subject in which the implant is positioned (Paragraph [0054]; based upon registration of image data to the patient 36, the tracked and determined position of the cochlear implant 226 may be illustrated relative to the image 84 on a selected one or more display devices 38, 40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the method of Carcieri-129 in view of Pathak, Hendricks, Carcieri-081, and Tsay to have included displaying the determined tracked pose of the implant with a display device relative to an image of a subject in which the implant is positioned because it would have allowed the operator to confirm the implant is properly located in the final location (Tsay, Paragraph [0104]).
Regarding claim 17, together Carcieri-129, Pathak, Hendricks, and Carcieri-081 teaches all of the limitations of claim 11 as noted above.
Carcieri-129 further teaches a storage system (Paragraph [84]; loud or other central storage 1508 with a database 1510, Fig. 15) in communication with the navigation system (Paragraph [84]; communication between system elements; Paragraph [89]; the system maintains a large database of patient population MRs);
and storing the determined tracked pose with the storage system (Paragraph [259]; a large database of lead contact positions).
Together Carcieri-129, Hendricks, and Carcieri-081 does not explicitly teach a tracking system;
wherein the navigation system is further configured to:
determine the tracked pose of the implant with the tracking system.
Tsay, however, teaches a method and system for implanting an electrode (Paragraph [0007]; provide navigation for tracking an instrument… instrument may be an instrument to assist in a procedure and/or may be a permanently implanted device) comprising receiving a plurality of signals (Paragraph [0038]; transmit signals from the tracking device 70) that relates to at least one of (i) at least one tracked pose of an implant (Paragraph [0052]; navigation system 20 may allow for tracking of selected portions of the cochlear implant 226… configured to allow for a determination of six degree of freedom position (including location and orientation)) or (ii) at least one volume of activation generated by the implant at the received tracked pose (Paragraph [0084] and [0089]; pairwise capacitance between all of the electrodes relative to each of the other electrodes may be made in block 368; Measured capacitance may be based upon an applied voltage on the implantable device 226 between the various electrodes and the implantation system); and
teach a tracking system (Paragraph [0028]; electropotential (EP) tracking system 22 and an electromagnetic (EM) tracking system 24 can be used to track one or more instruments… such as a lead used as a part of an implantable medical device (IMD));
wherein the navigation system is further configured to:
determine the tracked pose of the implant with the tracking system (Paragraph [0055]-[0057]; signal from the tracking device 250 is used to determine the position, including three-dimensional location and one or more orientation in the space of the tracking device 250 therefore, the instrument; can be used to show or determine a specific position of a plurality of points along the length of the body 230).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Carcieri-129 in view of Pathak, Hendricks and Carcieri-081 to have included a tracking system; wherein the navigation system is further configured to: determine the tracked pose of the implant with the tracking system as taught by Tsay because it would have allowed optimization of electrode positions and shape during the procedure (Tsay, paragraph [0098] and [0129]) which would have reduced the procedure times and improved the efficacy of the procedure by ensuring the electrodes are placed properly.
Regarding claim 18, together Carcieri-129, Pathak, Hendricks, Carcieri-081, and Tsay teach all of the limitations of claim 17 as noted above.
Carcieri-129 further teaches the outcome is classified into at least a first outcome and a second outcome (Paragraph [119]; The condition can include therapeutic effects, side effects);
wherein the determined correlation includes a relationship between at least the tracked pose and the first outcome or the second outcome (Paragraph [152]; configured to transform the VOAs to a single common atlas space and find an area included in the group associated with the side effect (or therapeutic effect));
wherein the first outcome is a good outcome and the second outcome is an undesirable outcome (Paragraph [119]; The condition can include therapeutic effects, side effects; A therapeutic effect is considered to be a good outcome, a side effect is considered to be an undesirable outcome).
Regarding claim 19, together Carcieri-129, Pathak, Hendricks, Carcieri-081, and Tsay teach all of the limitations of claim 17 as noted above.
Tsay further teaches a display device to display the determined tracked pose of the implant relative to an image of a subject in which the implant is positioned (Paragraph [0054]; based upon registration of image data to the patient 36, the tracked and determined position of the cochlear implant 226 may be illustrated relative to the image 84 on a selected one or more display devices 38, 40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the method of Carcieri-129 in view of Pathak, Hendricks, Carcieri-081, and Tsay to have included displaying the determined tracked pose of the implant with a display device relative to an image of a subject in which the implant is positioned because it would have allowed the operator to confirm the implant is properly located in the final location (Tsay, Paragraph [0104]).
Regarding claim 20, together Carcieri-129, Pathak, Hendricks, Carcieri-081, and Tsay teach all of the limitations of claim 19 as noted above.
Carcieri-129 further teaches an imaging system configured to acquire image data of the subject to generate the image (Paragraph [4]; using a computed tomography (CT) scanner device, a magnetic resonance imaging (MRI) device, or any other imaging modality; Paragraph [66]-[67]; MR or CT system used to store lead location).
Response to Arguments
Claim Rejections under – 35 U.S.C. § 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Examiner would like to point out the newly presented art of Pathak teaches generating, based on the determined correlation and anatomical image data of the current subject, a recommended implant trajectory comprising an entry point and an insertion angle specific to the current subject as noted in the rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anh Tuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEAN N EDUN/Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
7/24/26
Prosecution Insights