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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/5/2026 has been entered.
Status of the Claims
The status of the claims as of the response filed 2/5/2026 is as follows: Claims 1-20, 31 are cancelled, and all previously given rejections for these claims are considered moot. Claims 21-24, 26, 28-30, 32-33, 37, and 39 are currently amended. Claims 25, 27, 34-36, 38, and 40 are as previously presented. Claim 41 is new. Claims 21-30 and 32-41 are currently pending in the application and have been considered below. Applicant’s arguments have been fully considered.
Response to Amendment
Rejection Under 35 USC 112(b)
The independent claims have been amended to correct the indefinite language identified in para. 12 of the final rejection mailed 12/5/2025 such that the corresponding 35 USC 112(b) rejections are withdrawn.
Rejection Under 35 USC 101
The claims have been amended to include steps for processing one or more of a plurality of pre-operative images and a user input identifying an object to automatically determine a route to access the object, generating and providing an overlay of the determined route, processing a plurality of real-time intraoperative images received during a surgical procedure to compare and confirm the location of the object and the determined route, etc. Such limitations in combination with the other steps of each independent claim (such as the receipt of a model, receipt of real-time images, details of interaction with the generated GUI, etc.) integrate the recited abstract idea into a practical application by facilitating real-time image processing during a surgical procedure for comparison to previous image analysis in a manner that addresses the visualization challenges of current less invasive surgical object removal techniques as outlined on Pgs 14-15 of Applicant’s response filed 2/5/2026. Accordingly, the 35 USC 101 eligibility rejections are withdrawn.
Rejection Under 35 USC 103
The amendments made to the claims introduce limitations that are not fully addressed in the previous office action, and thus the corresponding 35 USC 103 rejections are withdrawn. However, Examiner will consider the amended claims in light of an updated prior art search and address their patentability with respect to prior art below.
Response to Arguments
Rejection Under 35 USC 103
Applicant’s arguments on pages 18-20 of the response directed to alleged deficiencies of Vollmer and the other previously cited prior art references with respect to the intra-operative comparison and confirmation steps 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.
Claim Interpretation
Claim 37 includes the limitation “wherein, based on the confirming, the stone is accessed and removed via the route during the medical procedure.” Examiner notes that claim 37 is directed to a non-transitory computer readable medium storing instructions, which, when executed by one or more processors of a computing system, execution various positively recited operations such as receiving a model, identifying a stone, determining one or more characteristics of the stone, transmitting instructions to a user device, determining a route to access the stone, receiving a plurality of real-time images from a second imaging device, comparing the plurality of real-time images to the updated model, and confirming various aspects of the surgical plan based on the comparing. The inclusion of the final “wherein” clause describing the access and removal of the stone during the medical procedure does not appear to be a function positively performed by the computer-readable medium, and there is no description of how such a function would actually be performed by the medium or processors. Accordingly, this limitation is interpreted as an intended use or result of the confirmed surgical plan (e.g. for performance by a human user responsive to completing surgical planning with the computing components) and is not considered patentably limiting because it does not limit the computer-readable medium of the claim to a particular structure or function. See MPEP 2111.04(I), which discusses the interpretation of “wherein” clauses: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are: (A) ‘adapted to’ or ‘adapted for’ clauses; (B) ‘wherein’ clauses; and (C) ‘whereby’ clauses.”
Claim Rejections - 35 USC § 103
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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 21-22, 25-26, 28-29, 33, 35-36, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US 20160070436 A1) in view of Olson et al. (US 20130172906 A1).
Claim 21
Thomas teaches a method implemented by a computing system (Thomas [0196]-[0200], noting a computing system for implementing the functions of the invention), the method comprising:
receiving a model of an anatomical structure, wherein the model is generated based on a plurality of images of the anatomical structure captured by one or more first imaging devices prior to a medical procedure, and wherein the model includes an object associated with the anatomical structure that is to be accessed during the medical procedure (Thomas [0086], noting acquisition of pre-operative images containing a surgical target in a patient’s anatomy from at least one 3D imaging modality);
providing, to a user device communicatively coupled to the computing system, a user interface for display on the user device, the user interface including the model and a menu, wherein, receiving, from the user device, the input identifying the object that is provided to the user interface (Thomas [0086], [0104], [0113]-[0114], [0128]-[0129], noting a user interface allows a user to identify a surgical target (e.g. a region or volume of interest representing an object like a lesion, tumor, or other resection target as in [0114]) in the pre-operative images; see also Fig. 7, showing an example of a displayed user interface with displayed pre-operative images and various menu options (e.g. review, regions, targets, trajectory, sulcal paths, craniotomy, export, as well as an image-based toolbar menu depicted in the top left quadrant));
processing one or more of the plurality of images based, in part, on the input identifying the object to automatically determine a route to access the object during the medical procedure (Thomas [0086], [0088], noting the system may use the pre-operative images to automatically determine entry points and a route from an entry point to the identified surgical target);
generating and providing, to the user device, an overlay including the route, wherein the user device displays the overlay on the model to provide a visualization of the route on the user interface (Thomas [0089], [0137], [0201], noting the one or more generated surgical trajectory paths are visually displayed over the pre-operative images for a surgeon to review);
receiving, from a second imaging device communicatively coupled to the computing system, a plurality of real-time images of the anatomical structure, wherein the plurality of real-time images are captured by the second imaging device during the medical procedure and include the object (Thomas [0139], [0183]-[0185], noting real-time intra-operative images of the surgical target are acquired using other imaging modalities once the procedure has been started);
processing the plurality of real-time images for comparison to the model; and confirming, based on the comparison, a location of the object included in the model and the route automatically determined and included in the displayed overlay (Thomas [0019], [0141]-[0143], [0183]-[0185], noting the intra-operative images are used as a basis for comparison to the pre-operative images to confirm or update the identified location of the surgical target and update the planned surgical path in real-time if needed; Examiner notes that a route not needing to be updated is functionally equivalent to ‘confirming’ the planned route).
In summary, Thomas teaches a pre- and intra-operative surgical planning system that utilizes an interactive user interface to allow a user such as a surgeon to designate or identify surgical targets in pre-operative images. Though the interface is depicted as including selectable menu options as in Fig. 7 and described in at least [0079], [0086], & [0186] as including point-and-click or touchscreen functionality, Thomas fails to explicitly disclose displaying a prompt requesting an object identification input from a user specifically based on a selection of a menu option from the menu, and receiving the user input specifically responsive to the prompt. However, Olson teaches an analogous surgical planning system that includes a menu with various selectable options to control the operating mode of the system, for example entering a mode that prompts a user to provide user input to designate or confirm a lesion/target location visually depicted in a medical image, e.g. via a plus sign or crosshairs (Olson Figs. 19a-h, [0134], [0137], [0157]-[0159], [0162]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the menu-enabled surgical target identification user interface of Thomas to include selection of a menu option to enter a target designation/confirmation mode and display of visual prompts for identifying/confirming the targets (e.g. plus signs or crosshairs) responsive to selection of the menu option as in Olson in order to allow the user to select and easily perform the desired operating mode of the system (e.g. surgical target identification/confirmation), thereby improving usability of the user interface (as suggested by Olson [0134]).
Claim 22
Thomas in view of Olson teaches the method of claim 21, and the combination further teaches wherein the input is a first input and the method further comprises: receiving, from the user device, a second input comprising (Thomas [0086], [0088], noting the user may manually specify aspects of the surgical path on the user interface such as access points and trajectories for inclusion in the surgical plan). Though the present combination further specifies that inputs may be provided using input devices like touch screens or gesture control components (Thomas [0079], [0089], [0186]), it fails to explicitly disclose that the second input identifying a portion of the route on the displayed model comprises a dragging input across the user interface. However, Olson further teaches that identifying a line or path on an anatomical model for surgical planning may be manually provided via user dragging motions on a touch screen display (Olson [0136], [0141]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the touchscreen-capable interface of the combination to specifically allow a dragging motion as in Olson as the manual input for identifying a path or trajectory of a surgical device during a surgical procedure in order to facilitate a simple and intuitive method of manually providing a desired surgical route during preoperative planning (as suggested by Olson title, [0134], [0255]).
Claim 25
Thomas in view of Olson teaches the method of claim 21, and the combination further teaches: determining one or more characteristics of the object, the one or more characteristics including a dimension of the object, a density of the object, a composition of the object, a location of the object, or an orientation of the object (Thomas [0086], [0105], [0113]-[0114], [0128], noting characteristics such as location and volume (i.e. a dimension) of the surgical target may be determined).
Claim 26
Thomas in view of Olson teaches the method of claim 25, and the combination further teaches wherein the route is automatically determined further based on the one or more characteristics of the object (Thomas [0086], [0088], [0105], [0134]-[0136], noting the system may uses the location and/or volume of the target to automatically determine entry points and a route from an entry point to the identified surgical target).
Claim 28
Thomas in view of Olson teaches the method of claim 21, and the combination further teaches wherein the input is a first input and the method further comprises: receiving, from the user device, a second input manipulating the model; and providing, to the user device for display, a modified version of the model corresponding to the manipulation (Thomas [0060], noting displayed 3D images are dynamic computer models with interfaces allowing for rotation and depth selection, indicating that a user may provide a rotation or depth selection input and the displayed model would be modified to comply with the desired visual parameters).
Claim 29
Thomas in view of Olson teaches the method of claim 21, and the combination further teaches: receiving patient data associated with a patient undergoing the medical procedure; receiving patient data associated with a plurality of other patients; comparing the patient data associated with the patient to the patient data associated with the plurality of other patients to identify one or more reference patient profiles; and automatically determining the route further based on the one or more reference patient profiles (Thomas [0091], [0098], [0105], noting current patient data (e.g. type of procedure, type of anatomy) is used to select matching historical reference and/or atlas data (i.e. reference patient profiles associated with a plurality of other patients) for use in automatically determining the surgical paths).
Claim 33
Thomas teaches a computing system comprising: at least one memory storing instructions; and at least one processor operatively connected to the at least one memory and configured to execute the instructions to perform operations (Thomas [0196]-[0200]), including:
receiving a model of an anatomical structure, wherein the model is generated based on a plurality of images of the anatomical structure captured by one or more first imaging devices prior to a medical procedure, and wherein the model includes an object associated with the anatomical structure that is to be accessed during the medical procedure (Thomas [0086], noting acquisition of pre-operative images containing a surgical target in a patient’s anatomy from at least one 3D imaging modality);
providing, to a user device in communication with the computing system, a user interface for display on the user device, the user interface including the model and a menu, wherein, (Thomas [0086], [0104], [0113]-[0114], [0128]-[0129], noting a user interface allows a user to identify a surgical target (e.g. a region or volume of interest representing an object like a lesion, tumor, or other resection target as in [0114]) in the pre-operative images; see also Fig. 7, showing an example of a displayed user interface with displayed pre-operative images and various menu options (e.g. review, regions, targets, trajectory, sulcal paths, craniotomy, export, as well as an image-based toolbar menu depicted in the top left quadrant));
performing image processing on one or more of the plurality of images based, in part, on the input identifying the object (Thomas [0086], [0088], [0105], noting the system performs image processing of the images of the identified surgical target) to:
determine one or more characteristics of the object identified by the input (Thomas [0086], [0105], [0113]-[0114], [0128], noting characteristics such as location and volume (i.e. a dimension) of the surgical target may be determined); and
determine a route to access the object during the medical procedure further based on the one or more characteristics of the object (Thomas [0086], [0088], [0105], [0134]-[0136], noting the system may use the location and/or volume of the target to automatically determine entry points and a route from an entry point to the identified surgical target);
generating and providing, to the user device, an overlay that includes the route and is associated with the plurality of images comprising the model to cause the user device to display the overlay on the model included in the user interface (Thomas [0089], [0137], [0201], noting the one or more generated surgical trajectory paths are visually displayed over the pre-operative images for a surgeon to review);
receiving, from a second imaging device communicatively coupled to the computing system, a plurality of real-time images of the anatomical structure or the object, wherein the plurality of real-time images are captured by the second imaging device during the medical procedure and include the object (Thomas [0139], [0183]-[0185], noting real-time intra-operative images of the surgical target are acquired using other imaging modalities once the procedure has been started);
performing image processing of the plurality of real-time images for comparison to the model; and confirming, based on the comparison, a location of the object included in the model, the one or more characteristics of the object determined, and the route determined and included in the displayed overlay (Thomas [0019], [0141]-[0143], [0183]-[0185], noting the intra-operative images are used as a basis for comparison to the pre-operative images to confirm or update the identified location (i.e. characteristic) of the surgical target and update the planned surgical path in real-time if needed; Examiner notes that a route not needing to be updated is functionally equivalent to ‘confirming’ the planned route).
In summary, Thomas teaches a pre- and intra-operative surgical planning system that utilizes an interactive user interface to allow a user such as a surgeon to designate or identify surgical targets in pre-operative images. Though the interface is depicted as including selectable menu options as in Fig. 7 and described in at least [0079], [0086], & [0186] as including point-and-click or touchscreen functionality, Thomas fails to explicitly disclose displaying a prompt requesting an object identification input from a user specifically based on a selection of a menu option from the menu, and receiving the user input specifically responsive to the prompt. However, Olson teaches an analogous surgical planning system that includes a menu with various selectable options to control the operating mode of the system, for example entering a mode that prompts a user to provide user input to designate or confirm a lesion/target location visually depicted in a medical image, e.g. via a plus sign or crosshairs (Olson Figs. 19a-h, [0134], [0137], [0157]-[0159], [0162]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the menu-enabled surgical target identification user interface of Thomas to include selection of a menu option to enter a target designation/confirmation mode and display of visual prompts for identifying/confirming the targets (e.g. plus signs or crosshairs) responsive to selection of the menu option as in Olson in order to allow the user to select and easily perform the desired operating mode of the system (e.g. surgical target identification/confirmation), thereby improving usability of the user interface (as suggested by Olson [0134]).
Claim 35
Thomas in view of Olson teaches the computing system of claim 33, and the combination further teaches wherein the input is a first input and the operations further comprise: receiving, from the user device, a second input identifying a portion of the route on the displayed model that is provided to the user interface, wherein the route is determined further based on the second input such that the route includes the portion of the route identified by the second input (Thomas [0086], [0088], noting the user may manually specify aspects of the surgical path on the user interface such as access points and trajectories for inclusion in the surgical plan).
Claim 36
Thomas in view of Olson teaches the computing system of claim 33, and the combination further teaches: prior to providing the user interface, automatically identifying the object in the model, wherein the automatically identified object is visually indicated in the model included in the user device, and the prompt requesting input via the user device to identify the object includes a request to confirm the automatically identified object (Thomas [0086], [0113]-[0114], noting image segmentation may be employed to automatically identify a region of interest like a lesion or tumor; see also [0086], [0138], noting an identified surgical target may be confirmed by a user via prompting at the user interface).
Claim 41
Thomas in view of Olson teaches the method of claim 21, and the combination further teaches wherein the route is one of a plurality of potential routes automatically determined by the processing of the one or more of the plurality of images; the overlay is generated to include each of the plurality of potential routes for display in a visually distinct manner from one another; and an indication of a selection of the route from among the plurality of potential routes is received via the user interface (Thomas [0086], [0088]-[0089], [0102]-[0103], [0136]-[0137], noting multiple candidate trajectory paths are automatically determined and displayed for clinician selection at the user interface; a final selection of a path is established for storage and/or exportation to a navigation system as noted in [0137]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas and Olson as applied to claims 21-22 above, and further in view of Baker (US 20140270441 A1).
Claim 23
Thomas in view of Olson teaches the method of claim 22, and the combination further teaches wherein the one or more of the plurality of images are processed further based on the second input, and wherein automatically determining the route comprises: automatically identifying, using one or more image recognition processes and the portion of the route identified by the second input, a remaining portion of the route (Thomas [0088], [0164], noting the system may use image-based algorithms to utilize a selected entry point (i.e. part of the second input that may be provided manually by the user as in [0086]) to identify appropriate paths from the entry point to the selected surgical target).
Though the present combination teaches use of a second input identifying a portion of a surgical route (e.g. an entry point) to determine the remaining portion of the route (e.g. the trajectory connecting the entry point to a surgical target), it fails to explicitly disclose utilizing a user-specified portion of the trajectory/path itself to automatically identify a remaining portion of the trajectory/path as Applicant appears to intend. However, Baker teaches an analogous surgical planning system that allows a user to input a partial path of a surgical operation across a portion of a displayed 3D patient representation (Baker [0075], [0078], noting a clinician can manipulate a lead line representing a surgical path on a 3D model of a patient’s anatomy, as well as add waypoints for the path), facilitates the automatic completion of the partial path by a computerized method (Baker [0079], [0083], noting a pathway planning module automatically completes the pathway based on the clinician’s input lead lines and pathway waypoints) and displays the entire completed path (Baker [0083]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the surgical path planning method of the combination to include automatic completion of a user-input trajectory/path as in Baker in order to make use of more effective automated pathway planning systems while still giving the clinician more direct control over the final orientation of the surgical device with respect to the target’s anatomy (as suggested by Baker [0005]-[0006] & [0084]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas and Olson as applied to claims 21-22 above, and further in view of Scholl et al. (US 20160235480 A1).
Claim 24
Thomas in view of Olson teaches the method of claim 21, and the combination further teaches: prior to providing the user interface, automatically identifying the object in the model, wherein the automatically identified object is visually indicated in the model included in the user device, and (Thomas [0086], [0113]-[0114], noting image segmentation may be employed to automatically identify a region of interest like a lesion or tumor; see also [0086], [0138], noting an identified surgical target may be confirmed by a user via prompting at the user interface).
In summary, the present combination teaches a system that may first automatically identify a surgical target and then allow user confirmation at a user interface. Olson further teaches providing a prompt in various formats (e.g. symbolic, color-based, verbal prompt, etc.) to a user to confirm candidate target points at a user interface (Olson [0162]). However, the present combination fails to explicitly disclose the prompt including a text box requesting to confirm the automatically identified object and a progress indicator associated with the prompt. However, Scholl teaches an analogous surgical planning system that interchangeably provides both text box-based and verbalized prompts (as well as many other types of communication) to interact with a user to perform a given portion of a surgical planning workflow (Scholl [0131], [0170]-[0171], noting textual, audio, and/or visual means such as textual messages, text boxes, audible tones, colored icons or screens, blinking icons or screens, etc. to prompt an interaction with a user, e.g. during a setup portion of a workflow) as well as provides a progress indicator associated with the portion of the surgical planning workflow (Scholl [0134], noting once a user has completed all required steps of the setup portion of the surgical planning method, a graphic such as a check character may appear on the GUI to indicate completion, considered equivalent to a progress indicator). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the symbolic and/or verbalized surgical target confirmation prompts of the combination to specifically include a text box and a progress indicator as in Scholl in order to permit user interaction via a larger number of interchangeable modalities (e.g. using textual prompts instead of verbal prompts to convey the same information), thereby improving usability and accessibility of the system (e.g. in the case of deaf users), as well as in order to provide the user with a visual indicator of progress/completion of specific portions of the surgical planning workflow, thereby improving the user’s understanding of their progress or status within the planning workflow (as suggested by Scholl [0131] & [0134]).
Claims 27 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas and Olson as applied to claims 21 or 33 above, and further in view of Bharadwaj et al. (US 20160038247 A1).
Claim 27
Thomas in view of Olson teaches the method of claim 25, but the present combination fails to explicitly disclose wherein, based on a selection of another menu option from the menu, the one or more characteristics of the object are displayed on the user interface. However, Bharadwaj teaches an analogous surgical planning system with a user interface that allow selection of a menu option to display characteristics of a surgical object at the user interface (Bharadwaj Figs. 5A & 8, [0079], [0097], noting target details view shows details about a surgical target such as dimensions and other parameters (i.e. characteristics); different detail views may be displayed responsive to an “add target” button being clicked as in [0078] or responsive to a clinician selecting an existing treatment plan as in [0093]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the user interface of the combination to include a surgical target details view responsive to selection of a menu option as in Bharadwaj in order to allow a user to drill down into specific details of a given surgical target, thereby improving usability of the user interface (as suggested by Bharadwaj [0079] & [0097]).
Claim 34
Thomas in view of Olson teaches the computing system of claim 33, but the present combination fails to explicitly disclose wherein, based on a selection of another menu option from the menu, the one or more characteristics of the object are displayed on the user interface. However, Bharadwaj teaches an analogous surgical planning system with a user interface that allow selection of a menu option to display characteristics of a surgical object at the user interface (Bharadwaj Figs. 5A & 8, [0079], [0097], noting target details view shows details about a surgical target such as dimensions and other parameters (i.e. characteristics); different detail views may be displayed responsive to an “add target” button being clicked as in [0078] or responsive to a clinician selecting an existing treatment plan as in [0093]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the user interface of the combination to include a surgical target details view responsive to selection of a menu option as in Bharadwaj in order to allow a user to drill down into specific details of a given surgical target, thereby improving usability of the user interface (as suggested by Bharadwaj [0079] & [0097]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas and Olson as applied to claim 21 above, and further in view of Bangera et al. (US 20140039658 A1).
Claim 30
Thomas in view of Olson teaches the method of claim 21, and the combination further teaches wherein the route includes an insertion site,buttons allow a user to select various functions or modes of the system (Olson [0134]), such that the present combination is considered to suggest exporting a surgical plan based on user selection of a menu button. However, the present combination does not specify that the destination of the exported surgical plan is to print a template, and thus fails to explicitly disclose generating a patient template that indicates the insertion site, wherein the patient template includes a first marking identifying a location for needle insertion and a second marking identifying a needle trajectory following insertion, and wherein, based on a selection of another menu option from the menu, the patient template is printed for transfer to a patient undergoing the medical procedure.
However, Bangera teaches an analogous surgical planning system with a function for printing a generated patient template depicting markings that identify an insertion site and needle trajectory on a sheet for transfer to a patient’s body (Bangera abstract, Fig. 2, Fig. 36 element 3630, [0109], [0221], noting the physical printing of a custom template as a sheet based on imaging of a particular patient, wherein the template has one or more needle access regions and associated fiducial markings identifying the appropriate insertion site and/or trajectory parameters like depth when transferred to a patient). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the surgical plan export function as in the combination to include generating and printing a custom template with insertion site and needle trajectory markings on a sheet as in Bangera in order to facilitate the user-directed production of a physical guide to aid a medical practitioner in the correct placement of a needle during a treatment (as suggested by Bangera [0108]).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas and Olson as applied to claim 21 above, and further in view of Kukuk et al. (US 20080194945 A1).
Claim 32
Thomas in view of Olson teaches the method of claim 21, and the combination further teaches wherein the route includes an insertion site, (Thomas [0058], noting the trajectory paths include an entry point (i.e. insertion site); see also [0083], noting the system can include output devices like laser pointers (i.e. a light source operable to direct light during a surgical procedure)). Thomas further teaches that generated surgical plans may be exported to a navigation system (Thomas [0137]). However, the present combination makes no mention of an export destination being the laser pointer light source operable to direct light specifically on the location of the insertion site, and thus fails to explicitly disclose providing a location of the insertion site to a device comprising a light source, the light source operable to direct light on the location of the insertion site.
However, Kukuk teaches an analogous laser pointer light source device for identifying a surgical site in accordance with location data received from a computerized surgical trajectory planning system (Kukuk abstract, [0003]-[0006]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the surgical planning export and laser pointer integration functionality of the combination to specifically include providing the location data to the laser pointer light source as in Kukuk in order to provide a visible guide for needle placement in an effort to reduce procedure time and radiation exposure while improving targeting accuracy, as suggested by Kukuk [0003] & [0006].
Claims 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas in view of Olson and Liang et al. (US 20160374760 A1).
Claim 37
Thomas teaches a non-transitory computer readable medium storing instructions, which, when executed by one or more processors of a computing system, execute operations comprising (Thomas [0196]-[0200]):
receiving a model of an anatomical structure of a patient, the anatomical structure including a kidney and surrounding anatomy, wherein the model is generated based on a plurality of images of the anatomical structure captured by one or more first imaging devices prior to a medical procedure (Thomas [0086], noting acquisition of pre-operative images containing a surgical target in a patient’s anatomy from at least one 3D imaging modality; see also [0062], [0068], [0072], [0192], noting the system can be applied to surgery on any part of the patient’s anatomy, including the kidney per [0192]);
identifying, based on the model, a accessed and removed during the medical procedure (Thomas [0086], [0104]-[0105], [0113]-[0114], [0128]-[0129], noting automatic or manual identification of a surgical target in the pre-operative images, e.g. a lesion, tumor, or other target for resection (i.e. access and removal) as in [0114]);
determining, based on the model, one or more characteristics of the identified (Thomas [0086], [0105], [0113]-[0114], [0128], noting characteristics such as location and volume of the surgical target may be determined);
transmitting instructions to a user device communicatively coupled to the one or more processors to cause the user device to generate and display a user interface (Thomas Fig. 6, [0196], noting the computing components of the system are connected to various input/output devices and/or interfaces 460; examples of presented user interfaces are described throughout the reference and shown in at least Figs. 7-9 such that the system is considered to transmit instructions to the user interface to cause it to generate and display the user interfaces), the user interface comprising:
a panel displaying the model of the anatomical structure (Thomas Figs. 7-9, [0086], noting display of the pre-operative images); and
a menu including at least a first menu option and a second menu option (Thomas Fig. 7, showing an example of a displayed user interface with various menu options (e.g. review, regions, targets, trajectory, sulcal paths, craniotomy, export, as well as an image-based toolbar menu depicted in the top left quadrant), considered equivalent to a menu including at least first and second menu options), wherein:
(Thomas [0086], [0104], [0113]-[0114], [0128]-[0129], noting a user interface allows a user to confirm a surgical target in the pre-operative images); and
determining a route to access the (Thomas [0086], [0088], [0105], [0134]-[0136], noting the system may use the location and/or volume of the target to automatically determine entry points and a route from an entry point to the identified surgical target), wherein an updated model including the route is provided to the user device and displayed by the panel (Thomas [0089], [0137], [0201], noting the one or more generated surgical trajectory paths are visually displayed over the pre-operative images for a surgeon to review);
receiving, from a second imaging device communicatively coupled to the one or more processors, a plurality of real-time images of the anatomical structure of the patient, wherein the plurality of real-time images are captured by the second imaging device during the medical procedure and include the (Thomas [0139], [0183]-[0185], noting real-time intra-operative images of the surgical target are acquired using other imaging modalities once the procedure has been started);
comparing the plurality of real-time images to the updated model; and confirming, based on the comparing, the route, a location of the (Thomas [0019], [0141]-[0143], [0183]-[0185], noting the intra-operative images are used as a basis for comparison to the pre-operative images to confirm or update the identified location (i.e. characteristic) of the surgical target and update the planned surgical path in real-time if needed; Examiner notes that a route not needing to be updated is functionally equivalent to ‘confirming’ the planned route),
wherein, based on the confirming, the (Thomas [0084], [0141]-[0147], noting the system includes intra-operative and post-operative data and determinations, indicating that a surgical procedure (e.g. a resection to access and remove a target volume as in [0114]) is actually performed via a planned route).
In summary, Thomas teaches a pre- and intra-operative surgical planning system that utilizes an interactive user interface to allow a user such as a surgeon to designate or identify surgical targets in pre-operative images for any type of surgical procedure. Though the interface is depicted as including selectable menu options as in Fig. 7 and described in at least [0079], [0086], & [0186] as including point-and-click or touchscreen functionality, Thomas fails to explicitly disclose displaying a prompt requesting an object identification input from a user specifically based on a selection of the first menu option, receiving the user input specifically responsive to the prompt, and displaying the one or more determined characteristics of the identified object based on a selection of the second menu option. Further, although Thomas contemplates use of the system for any type of surgical procedure and even provides an example of kidney anatomy in [0192], it fails to explicitly disclose that the identified surgical target is a kidney stone.
However, Olson teaches an analogous surgical planning system that includes a menu with various selectable options to control the operating mode of the system, for example entering a mode that prompts a user to provide user input to designate or confirm a lesion/target location visually depicted in a medical image, e.g. via a plus sign or crosshairs (Olson Figs. 19a-h, [0134], [0137], [0157]-[0159], [0162]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the menu-enabled surgical target identification user interface of Thomas to include selection of a menu option to enter a target designation/confirmation mode and display of visual prompts for identifying/confirming the targets (e.g. plus signs or crosshairs) responsive to selection of the menu option as in Olson in order to allow the user to select and easily perform the desired operating mode of the system (e.g. surgical target identification/confirmation), thereby improving usability of the user interface (as suggested by Olson [0134]).
The combination of Thomas and Olson thus teach a surgical planning system with menu-based operating mode control that can determine surgical target characteristics like location and volume/mass, but still fail to explicitly disclose that the identified surgical target is a kidney stone and display of the one or more determined characteristics of the identified stone as one of the menu-selectable operating modes. However, Liang teaches an analogous image-based surgical planning system that is used for the specific purpose of planning a surgical removal of a kidney stone within a kidney anatomy (Liang [0003]-[0006]) that includes user interface functionality with various selectable options to control the operating mode of the system (Liang [0042]), for example entering a mode that determines and displays anatomical measurements relevant to the surgical procedure (Liang [0036]-[0040], [0045]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the anatomy-agnostic surgical planning system of the combination to specifically be utilized for kidney stone removal procedures as in Liang in order to adapt the system for use during a known type of surgical procedure that requires careful pre-operative planning (as suggested by Liang [0005]-[0006]). It would have been further obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the menu-based functional control of the system of the combination to include a selectable function for displaying determined measurements as in Liang in order to provide all procedure-relevant measurements easily and intuitively to the surgeon for improved treatment planning (as suggested by Liang [0040]). The result of such a combination would include the determination of surgical target characteristics like location or volume/mass (as in Thomas) for a kidney stone target (as in Liang), selection of a menu option to control operation of the user interface mode (as in Olson and Liang) so that the determined stone characteristics are displayed to a user.
Claim 38
Thomas in view of Olson and Liang teaches the non-transitory computer readable medium of claim 37, and the combination further teaches wherein the input is a first input and the user interface is further configured to receive a second input identifying a portion of the route on the model displayed in the panel, and the route included in the updated model is determined further based on the second input such that the route includes the portion of the route identified by the second input (Thomas [0086], [0088], noting the user may manually specify aspects of the surgical path on the user interface such as access points and trajectories for inclusion in the surgical plan).
Claim 39
Thomas in view of Olson and Liang teaches the non-transitory computer readable medium of claim 37, and the combination further teaches wherein the panel is a first panel, and the user interface further comprises: at least a second panel displaying an image, from the plurality of images, of the anatomical structure, wherein the first panel and the second panel are displayed on the user interface simultaneously (Thomas Fig. 7, noting a multi-panel for simultaneous display of orthogonal views of the 2D images and a 3D representation of the pre-operative anatomy).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas, Olson, and Liang as applied to claim 37 above, and further in view of Bangera.
Claim 40
Thomas in view of Olson and Liang teaches the non-transitory computer readable medium of claim 37, and the combination further teaches wherein the menu further includes a third menu option, and (Thomas Fig. 7, noting at least a third option in the depicted menu and toolbar). Thomas further teaches that generated surgical plans may be exported to a navigation system (Thomas [0137]), while Olson shows that multiple on-screen menu buttons allow a user to select various functions or modes of the system (Olson [0134]), such that the present combination is considered to suggest exporting a surgical plan based on user selection of a menu button. However, the present combination does not specify that the destination of the exported surgical plan is to print a template, and thus fails to explicitly disclose based on a selection of the third menu option, a patient template generated based on the route is printed for transfer to a patient undergoing the medical procedure.
However, Bangera teaches an analogous surgical planning system with a function for printing a generated patient template depicting markings that identify an insertion site and needle trajectory on a sheet for transfer to a patient’s body (Bangera abstract, Fig. 2, Fig. 36 element 3630, [0109], [0221], noting the physical printing of a custom template as a sheet based on imaging of a particular patient, wherein the template has one or more needle access regions and associated fiducial markings identifying the appropriate insertion site and/or trajectory parameters like depth when transferred to a patient). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the surgical plan export function as in the combination to include generating and printing a custom template with insertion site and needle trajectory markings on a sheet as in Bangera in order to facilitate the user-directed production of a physical guide to aid a medical practitioner in the correct placement of a needle during a treatment (as suggested by Bangera [0108]).
Conclusion
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/KAREN A HRANEK/Primary Examiner, Art Unit 3684
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