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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/16/2025 has been entered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 8-9, 11-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite an abstract idea as discussed below. This abstract idea is not integrated into a practical application for the reasons discussed below. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons discussed below.
Step 1 of the 2019 Guidance requires the examiner to determine if the claims are to one of the statutory categories of invention. Applied to the present application, the claims belong to one of the statutory classes of a process or product as a computer implemented method or a computer system/product.
Step 2A of the 2019 Guidance is divided into two Prongs. Prong 1 requires the examiner to determine if the claims recite an abstract idea, and further requires that the abstract idea belong to one of three enumerated groupings: mathematical concepts, mental processes, and certain methods of organizing human activity.
Regarding claim 1, the independent claim is directed to a method for providing a prospective surgical trajectory. The examiner notes that claim limitations “...adapting a generalized three-dimensional (3D) mesh brain representation to imaging data of a patient’s brain to generate a patient-specific 3D cortical surface representation representing a cortical surface of a brain structure of the patient; wherein the patient-specific 3D mesh cortical surface representation preserves point-based correspondences between mesh vertices of the generalized 3D mesh brain representation and mesh vertices of the patient-specific 3D mesh cortical surface representation; generating a prospective surgical trajectory representation that represents a prospective surgical trajectory; determining a level of safety for the prospective surgical trajectory based on a number of times the prospective surgical trajectory representation intersects the patient-specific 3D cortical surface representation, wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the patient-specific 3D cortical surface representation; providing a notification based on the determined level of safety for the prospective surgical trajectory” are directed to an abstract because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.”
Furthermore, the claim does not include additional elements which are sufficient to amount to significantly more than the abstract idea. The additional claim limitation of “generating and displaying...the prospective surgical trajectory representation overlaying a visual representation of the patient’s brain with a visual indicator indicating the determined level of safety for the prospective surgical trajectory” is merely outputting a result and does not include additional elements which are sufficient to amount to significantly more than the abstract idea. Furthermore, the claim element “a graphical user interface” does not include additional elements which are not sufficient to amount to significantly more than the abstract idea because a GUI is well known and routine.
In consideration of each of the relevant factors and the claim elements both individually and in combination, claim 1 is directed to an abstract ideas without sufficient integration into a practical application and without significantly more.
Regarding claim 2, the claim limitations “generating 3D hazard brain region representations using imaging data of the patient’s brain, the 3D hazard brain region representation representing the hazard brain region of the patient’s brain to be avoided during surgery; and determining the level of safety for the prospective surgical trajectory further comprises determining the level of safety for the prospective surgical trajectory based on a number of times the prospective surgical trajectory representation intersects the 3D hazard brain region representations” are further directed to an abstract because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.”
Regarding claim 3, the claim limitations “wherein the the 3D hazard brain region representations represent blood vessels located on or within the patient’s brain” are further directed to an abstract because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.”
Regarding claims 4-5, the claim limitations “the prospective surgical trajectory representation is generated in response to user input that identifies a target point within the patient’s brain and a prospective entry point for initially entering the brain structure, the prospective surgical trajectory connecting the target point and the prospective entry point” are further directed to an abstract because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.” The examiner notes that the user input can be just a user using his mind and pen and paper to draw and identify a target point in the image.
Regarding claims 6 and 8, the claims further recite limitations that directed to an abstract because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.”
Regarding claim 9, the independent claim is directed to a method for providing a prospective surgical trajectory. The examiner notes that claim limitations “...adapting a generalized three-dimensional (3D) brain representation to imaging data of a patient’s brain, generating a patient-specific 3D brain structure representation representing a brain structure of the patient; reducing the 3D brain structure representation in size; determining a level of safety for a prospective surgical trajectory based number of intersections between a prospective surgical trajectory representation representing the prospective surgical trajectory and an exterior boundary surface of the modified patient-specific 3D brain structure representation, wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the patient-specific 3D cortical surface representation” are directed to an abstract because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.”
Furthermore, the claim does not include additional elements which are sufficient to amount to significantly more than the abstract idea. The additional element of a generic computer components (“processor”) to execute the abstract ideas and does not add significantly more than the abstract idea because since the processor are merely a generic computer component with the computer being used as a tool for performing the recited calculations.
The additional claim limitation of “generating and displaying...the prospective surgical trajectory representation overlaying a visual representation of the patient’s brain with a visual indicator indicating the determined level of safety for the prospective surgical trajectory” is merely outputting a result and does not include additional elements which are sufficient to amount to significantly more than the abstract idea. Furthermore, the claim element “a graphical user interface” does not include additional elements which are sufficient to amount to significantly more than the abstract idea because a GUI is well known and routine.
In consideration of each of the relevant factors and the claim elements both individually and in combination, claim 9 is directed to an abstract ideas without sufficient integration into a practical application and without significantly more.
Regarding claims 11, the claim limitations “wherein modifying the patient-specific 3D brain structure representation in accordance with the surgical safety margins comprises reducing the patient-specific 3D brain representation in size in accordance with the surgical safety margins” and an erosion filter to remove voxel of the patient-specific 3D brain representation are further directed to an abstract because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.”
Regarding claims 12, the claim recited limitation that are further directed to an abstract because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.”
Regarding claims 13-15, the claim limitations “wherein modifying the 3D hazard brain region representations in accordance with the surgical safety margins comprises increasing the 3D hazard brain region representations in size in accordance with the surgical safety margins”, “...applying a dilation filter to expand the given 3D hazard region representation voxel-wise, and “ wherein increasing the 3D hazard brain region representations in size comprises, for the 3D hazard region representation, outwardly displacing individual voxels of a 3D boundary surface of the given 3D hazard region representation by a set amount along the individual voxels’ surface normals, the 3D boundary surface of the given 3D hazard region representation representing the exterior boundary surface of the hazard brain region represented by the given 3D hazard region representation” are further directed to an abstract because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.”
Regarding claim 16, the independent claim is directed to a method for providing a prospective surgical trajectory. The examiner notes that claim limitations “...adapting a generalized three-dimensional (3D) mesh brain representation to imaging data of a patient’s brain to generate a patient-specific 3D mesh cortical surface representation representing a cortical surface of a brain structure of the patient; in response to user input that identifies a target point within the brain structure and a prospective entry point for initially entering the brain structure, generating a prospective surgical trajectory representation representing a prospective surgical trajectory that connects the prospective entry point and the target point; determining a level of safety for the prospective surgical trajectory based on a number of times the prospective surgical trajectory representation intersects the patient-specific 3D mesh cortical surface representation, wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the patient-specific 3D cortical surface representation” are directed to an abstract because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.”
Furthermore, the claim does not include additional elements which are sufficient to amount to significantly more than the abstract idea. The additional element of a generic computer components (“processor”) to execute the abstract ideas and does not add significantly more than the abstract idea because since the processor are merely a generic computer component with the computer being used as a tool for performing the recited calculations.
The additional claim limitation of “generating and displaying...the prospective surgical trajectory representation overlaying a visual representation of the patient’s brain with a visual indicator indicating the determined level of safety for the prospective surgical trajectory” is merely outputting a result and does not include additional elements which are sufficient to amount to significantly more than the abstract idea. Furthermore, the claim element “a graphical user interface” does not include additional elements which are sufficient to amount to significantly more than the abstract idea because a GUI is well known and routine.
In consideration of each of the relevant factors and the claim elements both individually and in combination, claim 16 is directed to an abstract ideas without sufficient integration into a practical application and without significantly more.
Regarding claims 17-20, the claim limitations generating 3D hazard brain region representations using imaging data of the patient’s brain, the 3D hazard brain region representation representing the hazard brain region to be avoided during surgery; and determining the level of safety for the prospective surgical trajectory further, determining the level of safety for the prospective surgical trajectory based on proximity of the prospective surgical trajectory representation to the 3D hazard brain region representations, determining an extent to which the prospective surgical trajectory representation passes within a threshold distance to the 3D hazard brain region representations, computing, for each individual point of the prospective surgical trajectory representation, distance to 3D boundary surfaces of the 3D hazard brain region representations, the 3D boundary surface of the 3D hazard brain region representation representing an exterior boundary surface for hazard brain region represented by the given 3D hazard brain region representation, determining a number of computed distances that are less than the threshold, the prospective surgical trajectory representation comprises a 1D line, and the threshold distance is based in part on diameter of a surgical tool to be inserted into the brain structure along the prospective surgical trajectory are further directed to an abstract because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.”
Regarding claims 21 and 22, the claims further recite limitations that do not add significantly more than the abstract idea. Providing a color coding visual indicator is merely outputting result using display with colors and is not sufficient to amount to significantly more than the abstract idea.
Regarding claim 23, the claim further recite limitation that is abstract idea (i.e., patient-specific 3D mesh cortical surface representation”) because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. Furthermore, the claim limitation of a scan of the patient’s brain does not add significantly more than the abstract idea because receiving or obtaining an image of the patient’s brain is directed to extra solution activity.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 8 and 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 6, the claim limitation “a patient-specific 3D mesh brain representation” in line 4 is indefinite because it is unclear if this patient-specific 3D mesh brain representation is related to the 3D mesh brain representation that is already recited in claim 1 or separate patient-specific 3D mesh brain representation.
Regarding claim 8, the claim limitation “the brain structure” in lines 5 is indefinite because it is unclear what brain structure the claim is referring to since claims 1 and 6 do not recite any brain structure.
Regarding claim 23, the claim limitation “the brain structure” in lines 1 is indefinite because it is unclear what brain structure the claim is referring to since claim 1 does not recite any brain structure.
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 1-6, 8, 16-20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 2021/0343397; hereinafter Orr), in view of Zagorchev (US 2022/0108525), in view of Sela et al. (US 2016/0155232).
Regarding claim 1, Orr discloses a surgical planning system that automatically asses different potential trajectory paths and identify candidate trajectories for surgical systems. Orr shows a method (see abstract, fig. 2 and 3), comprising: adapting imaging data of a patient’s brain (see abstract; fig. 2 and 3), generating a 3D cortical surface representation representing a cortical surface of the patient’s brain (see fig. 2 and 3; par. [0065], [0072], [0161]); generating a prospective surgical trajectory representation that represents a prospective surgical trajectory (see fig. 2, 3, 4B; 7A, 7B, 9 and 12), determining a level of safety for the prospective surgical trajectory based on a number of times the prospective surgical trajectory representation intersects patient-specific 3D cortical surface representation (see “rank” in abstract; par. [0019]-[0024], [0032]-[0034]; [01113]). Furthermore, Orr shows generating and displaying, on a graphical user interface, the prospective surgical trajectory representation overlaying a visual representation of the patient’s brain with a visual indicator indicating the determined level of safety for the prospective surgical trajectory prospective surgical trajectory (see fig. 12; par. [0090]-[0092], [0168]).
But, Orr fails to explicitly state adapting a patient-specific 3D mesh brain cortical representation, wherein the patient-specific 3D mesh cortical surface representation preserves point-based correspondence between mesh vertices of the generalized patient-specific 3D mesh brain representation and mesh vertices of the patient-specific 3D mesh cortical surface representation, and wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the patient-specific 3D cortical surface representation.
Zagorchev discloses patient specific cortical surface tessellation into dipole patches. Zagorchev teaches adapting a 3D mesh brain cortical representation, wherein the patient-specific 3D mesh cortical surface representation preserves point-based correspondence between mesh vertices of the generalized 3D mesh brain representation and mesh vertices of the 3D mesh cortical surface representation (see abstract; [0022], [0029], [0030])
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of adapting a patient-specific 3D mesh brain cortical representation, wherein the patient-specific 3D mesh cortical surface representation preserves point-based correspondence between mesh vertices of the generalized 3D mesh brain representation and mesh vertices of the patient-specific 3D mesh cortical surface representation in the invention of Orr, as taught by Zagorchev, to provide an accurate patient specific anatomic features from 3D medical images.
But, Orr and Zagorchev fail to explicitly state wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the patient-specific 3D cortical surface representation.
Sela discloses a method and system for displaying surgical engagement paths. Sela teaches wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the patient-specific 3D cortical surface representation ([0055], [0061], [0062]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the patient-specific 3D cortical surface representation in the invention of Orr and Zagorchev, as taught by Sela, to provide an optical path for invasive brain surgery.
Regarding claim 2, Orr shows wherein: the method further comprises generating 3D hazard brain region representations using imaging data of the patient’s brain (see fig. 2 and 3; par. [0065], [0072], [0142], [0143], [0161]), the 3D hazard brain region representation representing the hazard brain region of the patient’s brain to be avoided during surgery (see “no go regions” in par. [0094], [0096]; fig. 4B; 7A; and 9) and determining the level of safety for the prospective surgical trajectory further comprises determining the level of safety for the prospective surgical trajectory based on a number of times the prospective surgical trajectory representation intersects the 3D hazard brain region representations (abstract; fig. 2 and 3; par. [0019]-[0024], [0032]-[0034]; [0094], [0096]; [0113]).
Regarding claim 3, Orr shows wherein of the 3D hazard brain region representations represent blood vessels located on or within the patient’s brain (see par. [0106]).
Regarding claim 4, Orr shows wherein: the prospective surgical trajectory representation is generated in response to user input that identifies a target point within the brain structure and a prospective entry point for initially entering the patient’s brain, the prospective surgical trajectory connecting the target point and the prospective entry point (see fig. 2, 3, 4B; 7A, 7B, 9 and 12); par. [0007], [0019]-[0024], [0032]-[0034]; [01113]).
Regarding claim 5, Orr shows wherein: the target point is within a first sub-cortical structure (see fig. 2, 3, 4B; 7A, 7B, 9 and 12); and one of the 3D hazard brain regions represents a second sub-cortical structure located within the brain structure (see fig. 2, 3, 4B; 7A, 7B, 9 and 12; par. [0065], [0072], [0142], [0143], [0161]).
Regarding claim 6, Orr shows wherein generating the 3D cortical surface representation comprises: adapting the generalized 3D representation for the brain structure based on imaging data of the patient’s brain (see fig. 2 and 3; par. [0065], [0072], [0161]); and generating the 3D cortical surface representation from the 3D representation for the brain structure (see fig. 2 and 3; par. [0065], [0072], [0161]), wherein the 3D cortical surface representation comprises a 3D boundary surface of the 3D representation for the brain structure (see fig. 2, 3, 4B; 7A, 7B, 9 and 12), and prior art Zagorchev teaches adapting a 3D mesh brain cortical representation, wherein the patient-specific 3D mesh cortical surface representation preserves point-based correspondence between mesh vertices of the generalized 3D mesh brain representation and mesh vertices of the 3D mesh cortical surface representation (see abstract; [0022], [0029], [0030]), and generating the patient-specific 3D mesh cortical surface representation from the patient-specific 3D brain mesh representation, wherein the patient-specific 3D mesh cortical surface representation comprises 3D boundary surface of the patient-specific 3D brain mesh representation (see abstract; [0022], [0029], [0030]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of adapting a 3D mesh brain cortical representation, wherein the patient-specific 3D mesh cortical surface representation preserves point-based correspondence between mesh vertices of the generalized 3D mesh brain representation and mesh vertices of the 3D mesh cortical surface representation, and generating the patient-specific 3D mesh cortical surface representation from the patient-specific 3D brain mesh representation, wherein the patient-specific 3D mesh cortical surface representation comprises 3D boundary surface of the patient-specific 3D brain mesh representation in the invention of Orr, as taught by Zagorchev, to provide an accurate patient specific anatomic features from 3D medical images.
Regarding claim 8, Orr, Zagorchev and Sela disclose the invention substantially as described in the 103 rejection above, furthermore, Zagorchev teaches a marching cubes algorithm to generate 3D image representation (see par. [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a marching cubes algorithm to generate 3D image representation in the invention of Orr, as taught by Zagorchev, to provide an accurate patient specific anatomic features from 3D medical images.
Regarding claim 16, Orr discloses a surgical planning system that automatically asses different potential trajectory paths and identify candidate trajectories for surgical systems. Orr shows system comprising: processing resources (see fig. 1, 2, 3, and 6; par. [0146]); and a non-transitory computer-readable medium (see par. [0146]), coupled to the processing resources (see fig. 1, 2, 3, and 6; par. [0146]), having stored therein instructions that when executed by the one or more processing resources cause the system to perform a method comprising: adapting imaging data of a patient’s brain (see abstract; fig. 2 and 3), generating a patient-specific 3D brain structure representation representing a brain structure of the patient (see fig. 2 and 3; par. [0065], [0072], [0161]), in response to user input that identifies a target point within the brain structure (see abstract; par. [0007], [0008]) and a prospective entry point for initially entering the brain structure (see fig. 2, 3, 4B; 7A, 7B, 9 and 12; par. [0019]-[0024], [0032]-[0034]; [0113]), generating a prospective surgical trajectory representation representing a prospective surgical trajectory that connects the prospective entry point and the target point (see fig. 2, 3, 4B; 7A, 7B, 9 and 12; par. [0019]-[0024], [0032]-[0034]; [0113]); determining a level of safety for the prospective surgical trajectory based on a number of times the prospective surgical trajectory representation intersects the patient-specific 3D cortical surface representation and proximity between the prospective surgical trajectory representation and the patient-specific 3D cortical surface representation (see “rank” in abstract; par. [0019]-[0024], [0032]-[0034]; [0113]. Furthermore, Orr shows generating and displaying, on a graphical user interface, the prospective surgical trajectory representation overlaying a visual representation of the patient’s brain with a visual indicator indicating the determined level of safety for the prospective surgical trajectory prospective surgical trajectory (see fig. 12; par. [0090]-[0092], [0168]).
But, Orr fails to explicitly state adapting a patient-specific 3D mesh brain surface cortical representation, wherein the adaption preserves point-based correspondence between mesh vertices of the generalized patient-specific 3D mesh brain representation and mesh vertices of the patient-specific 3D mesh cortical surface representation, and wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the patient-specific 3D cortical surface representation.
Zagorchev discloses patient specific cortical surface tessellation into dipole patches. Zagorchev teaches adapting a patient-specific 3D mesh brain cortical representation, wherein the adaption preserves point-based correspondence between mesh vertices of the generalized patient-specific 3D mesh brain representation and mesh vertices of the 3D mesh cortical surface representation (see abstract; [0022], [0030]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of adapting a 3D mesh brain cortical representation, wherein the 3D mesh cortical surface representation preserves point-based correspondence between mesh vertices of the generalized 3D mesh brain representation and mesh vertices of the 3D mesh cortical surface representation in the invention of Orr, as taught by Zagorchev, to provide an accurate patient specific anatomic features from 3D medical images.
But, Orr and Zagorchev fail to explicitly state wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the 3D cortical surface representation.
Sela discloses a method and system for displaying surgical engagement paths. Sela teaches wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the 3D cortical surface representation ([0055], [0061], [0062]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the 3D cortical surface representation in the invention of Orr and Zagorchev, as taught by Sela, to provide an optical path for invasive brain surgery.
Regarding claim 17, Orr shows wherein: the method further comprises generating a 3D hazard brain region representations using imaging data of the patient’s brain, the 3D hazard brain region representation representing the hazard brain region to be avoided during surgery (see fig. 2 and 3; par. [0065], [0072], [0142], [0143], [0161]); and determining the level of safety for the prospective surgical trajectory further comprises determining the level of safety for the prospective surgical trajectory based on proximity of the prospective surgical trajectory representation to the 3D hazard brain region representations (abstract; fig. 2 and 3; par. [0019]-[0024], [0032]-[0034]; [0092], [0094], [0096]; [0113]).
Regarding claim 18, Orr shows wherein determining the level of safety for the prospective surgical trajectory based on proximity of the prospective surgical trajectory representation to the 3D hazard brain region representations comprises determining an extent to which the prospective surgical trajectory representation passes within a threshold distance to the 3D hazard brain region representations (see par. [0092], [0126]).
Regarding claim 19, Orr shows wherein determining the extent to which the prospective surgical trajectory representation passes within a threshold distance to the 3D hazard brain region representations comprises: computing, for each individual point of the prospective surgical trajectory representation, distance to 3D boundary surfaces of the 3D hazard brain region representations (see fig. 2, 3, 7A-C, and 9; par. [0092], [0126], [0130], [0131], [0138], [0139]), the 3D boundary surface of the 3D hazard brain region representation representing an exterior boundary surface for the hazard brain region represented by the given 3D hazard brain region representation (see fig. 2, 3, 7A-C, and 9); and determining a number of computed distances that are less than the threshold distance (see fig. 2, 3, 7A-C, and 9; par. [0092], [0126], [0130], [0131], [0138], [0139]).
Regarding claim 20, Orr shows wherein: the prospective surgical trajectory representation comprises a 1D line ((see fig. 2, 3, 7A-C, and 9; par. [0092], [0126], [0130], [0131], [0138], [0139]); and the threshold distance is based in part on diameter of a surgical tool to be inserted into the patient’s brain along the prospective surgical trajectory (see fig. 2, 3, 7A-C, and 9; par. [0092], [0094], [0126], [0130], [0131], [0138], [0139]).
Regarding claim 23, Orr further shows a scan of the patient’s brain (see par. [0008]), wherein the imaging data comprises the scan (see par. [0008]).
Claims 9, 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 2021/0343397; hereinafter Orr), in view of Sela et al. (US 2016/0155232).
Regarding claim 9, Orr discloses a surgical planning system that automatically asses different potential trajectory paths and identify candidate trajectories for surgical systems. Orr shows a non-transitory computer-readable storage medium comprising instructions that, when executed by at least one processor of a computing system (see par. [0146]), cause the computing system to perform a method comprising: adapting a generalized 3D brain representation to imaging data of patient’s brain to generate a patient-specific 3D brain representation representing the patient’s brain (see fig. 2 and 3; par. [0065], [0072], [0161]), reducing the 3D brain structure representation in size in accordance with surgical safety margins ((see par. [0119], [0141], [0163]); determining a level of safety for a prospective surgical trajectory based on number of intersections between a prospective surgical trajectory representation representing the prospective surgical trajectory and an anterior boundary surface of the modified the patient-specific 3D brain representation (see “rank” in abstract; par. [0019]-[0024], [0032]-[0034]; [0113]). Furthermore, Orr shows generating and displaying, on a graphical user interface, the prospective surgical trajectory representation overlaying a visual representation of the patient’s brain with a visual indicator indicating the determined level of safety for the prospective surgical trajectory prospective surgical trajectory (see fig. 12; par. [0090]-[0092], [0168]).
But, Orr fails to explicitly state wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the 3D cortical surface representation.
Sela discloses a method and system for displaying surgical engagement paths. Sela teaches wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the 3D cortical surface representation ([0055], [0061], [0062]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the 3D cortical surface representation in the invention of Orr, as taught by Sela, to provide an optical path for invasive brain surgery.
Regarding claim 11, Orr shows wherein reducing the patient-specific 3D brain representation in size comprises applying an erosion filter to remove voxels of the patient-specific 3D brain representation (see par. [0119]).
Regarding claim 12, Orr shows wherein reducing the patient-specific 3D brain representation in size comprises inwardly displacing individual voxels of the patient-specific 3D brain representation by a set amount along downwards projections from surface normal of the individuals voxels’ (see par. [00119], and fig. 7A and 7B).
Regarding claim 13, Orr shows wherein the imaging data of the patient’s brain to generate a 3D hazard brain region representation representing a hazard brain region of the patient’s brain to be avoid during surgery and hazard brain region representation in size in accordance with the surgical safety margins (fig. 7A and 7B show the “NO-GO regions” with different size with smaller and increased size regions of NO-GO regions.
Regarding claim 15, Orr shows wherein increasing the 3D hazard brain region representations in size comprises, outwardly displacing individual voxels of a 3D boundary surface of the given 3D hazard region representation by a set amount along the surface normal of the individual voxels’ surface normal (see par. [00119], and fig. 7A and 7B). , the 3D boundary surface of the given 3D hazard region representation representing the exterior boundary surface of the hazard brain region represented by the given 3D hazard region representation (see par. [00119], and fig. 7A and 7B).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 2021/0343397; hereinafter Orr,) in view of Sela et al. (US 2016/0155232) as applied to claims 9 and 13 above, and further in view of Moeller (US 7,616,794).
Regarding claim 14, Orr and Sela disclose the invention substantially as described in the 102 rejection above, but fails to explicitly state applying a dilation filter to expand region representation voxel-wise.
Moeller discloses a system and method for automatic anatomical extraction from a medical image. Moeller teaches a dilation filter to expand region representation voxel-wise (see col. 6, lines 58-67).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a dilation filter to expand region representation voxel-wise in the invention of Orr and Sela, as taught by Moeller, to be able to expand the core structure of the NO-GO region to probe a more accurate surgical planning and protentional trajectory path.
Claim 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 2021/0343397; hereinafter Orr), in view of Zagorchev (US 2022/0108525), in view of Sela et al. (US 2016/0155232) as applied to claim 1 above, and further in view of Shelton, IV et al. (US 2022/0336097; relied on provisional application no. 63/174,674 filing date 04/14/2021; hereinafter Shelton).
Regarding claims 21 and 22, Orr, Zagorchev and Sela disclose the invention substantially as described in the 103 rejection above, furthermore, Orr shows generating and displaying, on a graphical user interface, the prospective surgical trajectory representation overlaying a visual representation of the patient’s brain with a visual indicator indicating the determined level of safety for the prospective surgical trajectory prospective surgical trajectory (see fig. 12; par. [0090]-[0092], [0168]), but Orr fails to explicitly state that the visual indicator comprises a color coding such as green, yellow and red versions.
Shelton discloses a risked based surgery device and teaches visual indicator to show risk values (see par. [0263] in PG pub. 2022/0336097 and par. [0060]-[0062] provisional application no. 63/174,674), and teaches green as first level of safety (see par. [0263]), yellow as a second level lower than first level of safety (see par. [0263] in PG pub. 2022/0336097 and par. [0060]-[0062] provisional application no. 63/174,674), and red as a third level lower than the second level of safety (see par. [0263] in PG pub. 2022/0336097 and par. [0060]-[0062] provisional application no. 63/174,674).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of visual indicator to show risk values, and teaches green as first level of safety, yellow as a second level lower than first level of safety, and red as a third level lower than the second level of safety in the invention of Orr, Zagorchev and Sela, as taught by Shelton, to provide a better visual display to the user during surgery to avoid any unnecessary risks to the patient.
Response to Arguments
Applicant’s remark on page 9 regards to Examiner not granting interview, the examiner is unaware of any interview request made by the Applicant. The examiner advises the Applicant to contact the examiner to schedule any interview that would help advance prosecution.
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
In response to Applicant’s arguments on pages 10-14, with respect to claim rejection under 35 USC 101, the examiner respectfully disagrees. The examiner maintains the independent claims 1, 9 and 16 are still rejected under 35 USC 101 because the claim recites limitations that are directed to an abstract because the claim limitation can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.” Furthermore, the claim does not include additional elements which are sufficient to amount to significantly more than the abstract idea. The additional claim limitation of “generating and displaying...the prospective surgical trajectory representation overlaying a visual representation of the patient’s brain with a visual indicator indicating the determined level of safety for the prospective surgical trajectory” is merely outputting a result and does not include additional elements which are sufficient to amount to significantly more than the abstract idea. Furthermore, the claim element “a graphical user interface” does not include additional elements which are not sufficient to amount to significantly more than the abstract idea because a GUI is well known and routine.
The Applicant argues that the claims should be eligible because the claims recite limitations that are directed to modified and manipulation of computer data structure and cannot be practically performed in the human mind, the examiner respectfully disagrees. The claims are merely directed to generating 3D image and patient-specific 3D mesh cortical surface representation representing a cortical surface of patient’s brain which can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen and paper. Furthermore, the Applicant argues that the independent claims provide a neurosurgeon with real time feed back on safety prospective surgical trajectory, which can simultaneously reduce surgical intervention time, however, the examiner notes that the claims does not recite actually performing any surgeries and limits providing visualization on a GUI with the prospective surgical trajectory representation overlaying a visual representation of the patient’s brain with a visual indicator indicating the determined level of safety for the prospective surgical trajectory which is merely outputting a result and does not include additional elements which are sufficient to amount to significantly more than the abstract idea.
In response to Applicant’s argument on pages 15-18, with respect to prior arts Orr and Sela, the examiner respectfully disagrees. Upon further consideration, the examiner maintains that combined invention of Orr, Zagorchev, and Sela does teach all the claims limitations set forth in claims 1 and 16, and combined invention of Orr and Sela does teach all the claim limitation set forth in claim 9. With respect to prior art Orr, the examiner notes Orr does teach Orr shows generating and displaying, on a graphical user interface, the prospective surgical trajectory representation overlaying a visual representation of the patient’s brain with a visual indicator indicating the determined level of safety for the prospective surgical trajectory prospective surgical trajectory (fig. 12; par. [0090]-[0092], [0168] disclose visual indicator in numbers 1-7 overlaid on a visual representation of the patient’s brain indicating determined level of safety for the prospective surgical trajectory).
Furthermore, the Applicant argues that Orr does not disclose ranking candidate surgical trajectories based on a number of time a candidate trajectory interests, the examiner respectfully disagrees. The examiner maintains that Orr does teach determining a level of safety for the prospective surgical trajectory based on a number of times the prospective surgical trajectory representation intersects patient-specific 3D cortical surface representation (see “rank” in abstract; par. [0019]-[0024], [0032]-[0034]; [01113]). Furthermore, the examiner maintains that that Sela does teach wherein the determined level of safety increases with a decreasing number of times the prospective surgical trajectory representation intersects the patient-specific 3D cortical surface representation (par. [0055], [0061], [0062] disclose assigning score based on intersections between path and tracts and number of time they intersects).
The examiner has provided new art Shelton to address new claims 21 and 22. WIth regards to new claim 23, the examiner notes that prior art Orr teaches a scan of the patient’s brain (see par. [0008]), wherein the imaging data comprises the scan (see par. [0008])
Conclusion
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/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797