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 .
Response to Amendment
The amendment filed 12/08/2025 has been entered. Claims 1-3, 5-6, and 8-15 remain pending in the application. Amendments to claims 1, 3 and 12-13, and new claims 14 and 15 are acknowledged.
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.
Claim(s) 1-15 are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “acquire a three-dimensional image of a brain of a subject including an abnormal area, wherein the three-dimensional image is represented by a plurality of pixels, and wherein a position of each of the plurality of pixels is represented by a coordinate value;”, “derive at least one path from a representative point of the abnormal area to a start position on a surface of the brain through an intermediate position at a bottom of a cerebral sulcus in the brain, wherein a distance between a coordinate value of a pixel corresponding to the representative point and a coordinate value of a pixel corresponding to the intermediate position is a shortest distance among distances between coordinate values of pixels corresponding to the bottom of the cerebral sulcus and the coordinate value of the pixel corresponding to the representative point of the abnormal area, and wherein a distance between a coordinate value of a pixel corresponding to the start position and the coordinate value of the pixel corresponding to the intermediate position is a shortest distance among distances between coordinate values of pixels corresponding to the surface of the brain and the coordinate values of the pixels corresponding to the bottom of the cerebral sulcus”, “set a craniotomy pattern for that traces the path, on a surface of a head of the subject included in the three-dimensional image.”, “superimpose the craniotomy pattern that traces he path on the three-dimensional image based on the coordinate values of the pixels thereof to generate a simulation image;”, and “display the simulation image on a display.” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking (deriving a path and setting a pattern), which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional element is “a processor” and “a display”. However, “a display” is well-known, conventional, or routine as evidenced by Thomas et al. (US 2016/0070436 A1) para [0060]. Additionally, a generic computer structure is not significantly more according to Alice v. CLS. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2-11 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Thus, claim(s) 1-3, 5-6, and 8-11 are rejected under 35 U.S.C. 101.
Claim 12 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 12 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “acquire a three-dimensional image of a brain of a subject including an abnormal area, wherein the three-dimensional image is represented by a plurality of pixels, and wherein a position of each of the plurality of pixels is represented by a coordinate value;”, “deriving at least one path from a representative point of the abnormal area to a start position on a surface of the brain through an intermediate position at a bottom of a cerebral sulcus in the brain, wherein a distance between a coordinate value of a pixel corresponding to the representative point and a coordinate value of a pixel corresponding to the intermediate position is a shortest distance among distances between coordinate values of pixels corresponding to the bottom of the cerebral sulcus and the coordinate value of the pixel corresponding to the representative point of the abnormal area, and wherein a distance between a coordinate value of a pixel corresponding to the start position and the coordinate value of the pixel corresponding to the intermediate position is a shortest distance among distances between coordinate values of pixels corresponding to the surface of the brain and the coordinate values of the pixels corresponding to the bottom of the cerebral sulcus”, “set a craniotomy pattern that traces the path, on a surface of a head of the subject included in the three-dimensional image.”, “superimposing the craniotomy pattern that traces the path on the three-dimensional image based on the coordinate values of the pixels thereof to generate a simulation image;”, and “display the simulation image on a display.” . This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking (deriving a path and setting a pattern), which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional element is “a display”. However, “a display” is well-known, conventional, or routine as evidenced by Thomas et al. (US 2016/0070436 A1) para [0060]. Additionally, a generic computer structure is not significantly more according to Alice v. CLS. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 12 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Thus, claim 12 is rejected under 35 U.S.C. 101.
Claim 13 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 13 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “a procedure for acquiring a three-dimensional image of a brain of a subject including an abnormal area, wherein the three-dimensional image is represented by a plurality of pixels, and wherein a position of each of the plurality of pixels is represented by a coordinate value”, “deriving at least one path from a representative point of the abnormal area to a start position on a surface of the brain through an intermediate position at a bottom of a cerebral sulcus in the brain, wherein a distance between a coordinate value of a pixel corresponding to the representative point and a coordinate value of a pixel corresponding to the intermediate position is a shortest distance among distances between coordinate values of pixels corresponding to the bottom of the cerebral sulcus and the coordinate value of the pixel corresponding to the representative point of the abnormal area, and wherein a distance between a coordinate value of a pixel corresponding to the start position and the coordinate value of the pixel corresponding to the intermediate position is a shortest distance among distances between coordinate values of pixels corresponding to the surface of the brain and the coordinate values of the pixels corresponding to the bottom of the cerebral sulcus;”, “setting a craniotomy pattern that traces the path, on a surface of a head of the subject included in the three-dimensional image”, “superimposing the craniotomy pattern that traces the path on the three-dimensional image based on the coordinate values of the pixels thereof to generate a simulation image;”, and “displaying the simulation image on a display.” . This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking (deriving a path and setting a pattern), which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional element is “a processor” and “a display”. However, “a display” is well-known, conventional, or routine as evidenced by Thomas et al. (US 2016/0070436 A1) para [0060]. Additionally, a generic computer structure is not significantly more according to Alice v. CLS. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 13 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Thus, claim 13 is rejected under 35 U.S.C. 101
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 and 4-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Thomas et al. (US 2016/0070436 A1).
Regarding claim 1, Thomas discloses a craniotomy simulation device comprising (abstract: “simulation systems”): a processor configured to acquire a three-dimensional image of a brain of a subject including an abnormal area ([0025]: “multiple code segments configured to produce a 3D static or animated image…”, [0082]: “may segment tissue structures such as tumors"), wherein the three-dimensional image is represented by a plurality of pixels, and wherein a position of each of the plurality of pixels is represented by a coordinate value ([0057]: ““image registration” refers to the process of transforming different sets of imaging data into one coordinate system”, [0164]: “given an MRI T1 image with segmentation into white matter, grey matter, sulci, and CSF, etc., and a surgical entry point and a target specified within the information, the system specifies a lattice of the image voxel centers and forms a graph of the 27-connected direct voxel neighbors. Each connection is given a weight based on the voxel label as white matter, grey matter, sulcus, or other”); derive at least one path from a representative point of the abnormal area to a start position on a surface of the brain ([0025]: " compute one or more point-wise trajectory paths relative to known points in the imaging volume that relate to a surgical outcome criteria", [0111]: “The starting region or collection of points is commonly used in DTI estimation to estimate voxels that collectively represent individual tracts.”) through an intermediate position at a bottom of a cerebral sulcus in the brain ([0085]: "can also include sulci based approach paths to minimize white matter and grey matter insertion damage.”, [0135]: “spatial location points may be inserted to define a piecewise linear path when turns are observed in the sulci.”, wherein the bottom of the sulcus be selected as the point), wherein a distance between a coordinate value of a pixel corresponding to the representative point and a coordinate value of a pixel corresponding to the intermediate position is a shortest distance among distances between coordinate values of pixels corresponding to the bottom of the cerebral sulcus and the coordinate value of the pixel corresponding to the representative point of the abnormal area ([0103]: “path of the shortest distance between the one or more target locations and the closest entry point”), and wherein a distance between a coordinate value of a pixel corresponding to the start position and the coordinate value of the pixel corresponding to the intermediate position is a shortest distance among distances between coordinate values of pixels corresponding to the surface of the brain and the coordinate values of the pixels corresponding to the bottom of the cerebral sulcus ([0103]: “path of the shortest distance between the one or more target locations and the closest entry point”, [0135]: “is configured to define a piecewise linear sulcal path that includes the engagement and target points as the two extreme beginning and end points respectively in the surgical path and additional spatial locations between the two extreme points”, wherein the path may be piecewise through intermediate points, and the path of the shortest distance is computed); set a craniotomy pattern that traces (Examiner’s Note: intended use of the claimed “craniotomy pattern,” i.e., capable of) the path, on a surface of a head of the subject included in the three-dimensional image ([0025]: "exporting the one or more such paths.", [0084]: “Visualization output(s)”); superimpose the craniotomy pattern that traces the path on the three-dimensional image based on the coordinate values of the pixels thereof to generate a simulation image ([0060]: “This display includes but is not limited to, stereoscopic displays, dynamic computer models with an interface allowing for rotation and depth selection, perspective views, and holographic displays.”, [0106]: “programmed to visually display a simulation of the surgical tool approaching the target along the one or more surgical paths and accessing all portions of the target to be engaged by the surgical instrument.”); and display the simulation image on a display ([0106]: “programmed to visually display a simulation.”).
Regarding claim 5, Thomas discloses the processor is configured to derive the path that passes through a cerebral sulcus other than a cerebral sulcus selected ([0086]: " The system could generate the best sulcal entry points based on, for example, minimizing the number of impacted fibres, distance from the sulcal boundary to the target, and volume of white and/or grey matter displaced by the approach path.", wherein as the system may suggest points other than the one designated, it may select a cerebral sulcus other than the selected entry point).
Regarding claim 6, Thomas discloses the processor is configured to derive the path that avoids an organ designated ([0090]: " a surgical trajectory path may include selecting one or more anatomical features to be avoided").
Regarding claim 7, Thomas discloses the processor is further configured to display a three-dimensional image of the head of the subject for which the craniotomy pattern is set, on a display unit as a simulation image ([0109]: " The 3D sulcal map is constructed using the MR data to generate a 3D surface map to represent the brain surface and clearly illustrate the sulcal folds or crevices that are present on the brain").
Regarding claim 8, Thomas discloses the processor is configured to display, on the display, the simulation image in which a point of view is shifted from the surface of the head of the subject to the abnormal area along the path ([0084]: "Visualization output(s) can include contextual volume imaging; point source imaging which involves imaging only the regions of interest that are important at that point of the surgical procedure;").
Regarding claim 9, Thomas discloses the processor is configured to display, on the display unit, the simulation image in which the path is highlighted ([0089]: "Once the one or more point-wise surgical trajectory paths have been produced they may be stored in the storage medium and visually displayed to the clinician").
Regarding claim 10, Thomas discloses the processor is configured to: derive a plurality of the paths ([0025]); set the craniotomy pattern for each of the plurality of paths ([0157]: “to determine an appropriate craniotomy, incision,”); and sort the plurality of paths in accordance with a distance from the abnormal area to a cerebral sulcus and display a sorting result on a display unit ([0093]: “[0093]: "The method also includes assigning a score to the one or more trajectory paths to quantify how well the one or more trajectory paths satisfy the surgical intent, and based on a comparison of these scores, the best surgical path is calculated... The lengths of the surgical paths could also be used to score the trajectories. ", [0085]: “sulci based approach paths”); in response to a first path among the plurality of paths being selected, superimpose the first path onto the three-dimensional image ([0106]: “Once the one or more surgical paths have been determined, the surgical/clinician team may wish to run simulations so that the system is programmed to visually display a simulation of the surgical tool approaching the target along the one or more surgical paths and accessing all portions of the target to be engaged by the surgical instrument.”); and in response to a second path among the plurality of paths being selected, superimpose the second path onto the three-dimensional image ([0106]).
Regarding claim 11, Thomas discloses the processor is configured to: derive a plurality of the paths ([0025]); set the craniotomy pattern for each of the plurality of paths ([0157]: “to determine an appropriate craniotomy, incision,”); and sort the plurality of paths in accordance with a distance from the abnormal area to the surface of the brain and display a sorting result on a display unit ([0093]: "The method also includes assigning a score to the one or more trajectory paths to quantify how well the one or more trajectory paths satisfy the surgical intent, and based on a comparison of these scores, the best surgical path is calculated... The lengths of the surgical paths could also be used to score the trajectories. ", [0086]: “from a surface location”).
Regarding claim 12, Thomas discloses a craniotomy simulation method comprising (abstract: “simulation systems”): acquiring a three-dimensional image of a brain of a subject including an abnormal area ([0025]: “multiple code segments configured to produce a 3D static or animated image…”, [0082]: “may segment tissue structures such as tumors") wherein the three-dimensional image is represented by a plurality of pixels, and wherein a position of each of the plurality of pixels is represented by a coordinate value ([0057]: ““image registration” refers to the process of transforming different sets of imaging data into one coordinate system”, [0077]: “Once the images are registered they form an input to a data analysis module”, wherein the image data is converted to a coordinate system for processing); deriving at least one path from a representative point of the abnormal area to a start position on a surface of the brain ([0025]: " compute one or more point-wise trajectory paths relative to known points in the imaging volume that relate to a surgical outcome criteria", [0111]: “The starting region or collection of points is commonly used in DTI estimation to estimate voxels that collectively represent individual tracts.”) through an intermediate position at a bottom of a cerebral sulcus in the brain ([0085]: "can also include sulci based approach paths to minimize white matter and grey matter insertion damage.”, [0135]: “spatial location points may be inserted to define a piecewise linear path when turns are observed in the sulci.”, wherein the bottom of the sulcus be selected as the point), wherein a distance between a coordinate value of a pixel corresponding to the representative point and a coordinate value of a pixel corresponding to the intermediate position is a shortest distance between the bottom of the cerebral sulcus and the representative point of the abnormal area ([0103]: “path of the shortest distance between the one or more target locations and the closest entry point”), and wherein a distance between the a coordinate value of a pixel corresponding to the start position and a coordinate value of a pixel corresponding to the intermediate position is a shortest distance among distances between coordinate values of pixels corresponding to the surface of the brain and the bottom of the cerebral sulcus ([0103]: “path of the shortest distance between the one or more target locations and the closest entry point”, [0135]: “is configured to define a piecewise linear sulcal path that includes the engagement and target points as the two extreme beginning and end points respectively in the surgical path and additional spatial locations between the two extreme points”, wherein the path may be piecewise through intermediate points, and the path of the shortest distance is computed); set a craniotomy pattern for tracing (Examiner’s Note: intended use of the claimed “craniotomy pattern,” i.e., capable of) the path, on a surface of a head of the subject included in the three-dimensional image ([0025]: "exporting the one or more such paths.", [0084]: “Visualization output(s)”); superimpose the craniotomy pattern for tracing the path on the three-dimensional image based on the coordinate values of the pixels thereof generate a simulation image ([0060]: “This display includes but is not limited to, stereoscopic displays, dynamic computer models with an interface allowing for rotation and depth selection, perspective views, and holographic displays.”, [0106]: “programmed to visually display a simulation of the surgical tool approaching the target along the one or more surgical paths and accessing all portions of the target to be engaged by the surgical instrument.”); and display the simulation image on a display ([0106]: “programmed to visually display a simulation.”).
Regarding claim 13, Thomas discloses a craniotomy simulation device comprising (abstract: “simulation systems”): a procedure for acquiring three-dimensional image of a brain of a subject including an abnormal area, ([0025]: “multiple code segments configured to produce a 3D static or animated image…”, [0082]: “may segment tissue structures such as tumors"), wherein the three-dimensional image is represented by a plurality of pixels, and wherein a position of each of the plurality of pixels is represented by a coordinate value ([0057]: ““image registration” refers to the process of transforming different sets of imaging data into one coordinate system”, [0077]: “Once the images are registered they form an input to a data analysis module”, wherein the image data is converted to a coordinate system for processing); a procedure for deriving at least one path from a representative point of the abnormal area to a start position on a surface of the brain ([0025]: " compute one or more point-wise trajectory paths relative to known points in the imaging volume that relate to a surgical outcome criteria", [0111]: “The starting region or collection of points is commonly used in DTI estimation to estimate voxels that collectively represent individual tracts.”) through an intermediate position at a bottom of a cerebral sulcus in the brain (([0085]: "can also include sulci based approach paths to minimize white matter and grey matter insertion damage.”, [0135]: “spatial location points may be inserted to define a piecewise linear path when turns are observed in the sulci.”, wherein the bottom of the sulcus be selected as the point) wherein a distance between a coordinate value of a pixel corresponding to the representative point and a coordinate value of a pixel corresponding to the intermediate position is a shortest distance between the bottom of the cerebral sulcus and the representative point of the abnormal area ([0103]: “path of the shortest distance between the one or more target locations and the closest entry point”), and wherein a distance between the start position and the intermediate position is a shortest distance among distances between coordinate values of pixels corresponding to the surface of the brain and the bottom of the cerebral sulcus ([0103]: “path of the shortest distance between the one or more target locations and the closest entry point”, [0135]: “is configured to define a piecewise linear sulcal path that includes the engagement and target points as the two extreme beginning and end points respectively in the surgical path and additional spatial locations between the two extreme points”, wherein the path may be piecewise through intermediate points, and the path of the shortest distance is computed); set a craniotomy pattern that traces (Examiner’s Note: intended use of the claimed “craniotomy pattern,” i.e., capable of) the path, on a surface of a head of the subject included in the three-dimensional image ([0025]: "exporting the one or more such paths.", [0084]: “Visualization output(s)”); superimpose the craniotomy pattern for tracing the path on the three-dimensional image to generate a simulation image based on the coordinate values of the pixels thereof ([0060]: “This display includes but is not limited to, stereoscopic displays, dynamic computer models with an interface allowing for rotation and depth selection, perspective views, and holographic displays.”, [0106]: “programmed to visually display a simulation of the surgical tool approaching the target along the one or more surgical paths and accessing all portions of the target to be engaged by the surgical instrument.”); and display the simulation image on a display ([0106]: “programmed to visually display a simulation.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-3 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas in view of Pak et al. (US 20160296242 A1).
Regarding claim 2, Thomas discloses the device of claim 1 and discloses the processor is configured to set the craniotomy pattern in accordance with a position of the path on the surface of the brain ([0157]: “surgical instrument and port planning to determine an appropriate craniotomy, incision,”), but fails to disclose a template selected from templates representing a plurality of standard craniotomy patterns respectively.
Pak discloses a method of conducted craniotomies using predetermined patterns (abstract) wherein the processor is configured to set the craniotomy pattern on the basis of a template selected from templates representing a plurality of standard craniotomy patterns (Fig 7 [0025]: “drilling pattern of FIG. 7”, Fig 9 [0028]: “drilling pattern of FIG. 7”, respectively in accordance with a position of the path on the surface of the brain ([0012]: “predetermining a drill hole pattern comprising a plurality of craniotomies to be drilled in the target skull and creating the drill hole pattern by drilling the plurality of craniotomies. The predetermined drill hole pattern may be selected to facilitate creation of a cranial window in the target skull.”).
Thomas and Pak are considered analogous art as both pertain to craniotomy procedures. As Thomas discloses that the incision pattern may be predetermined but does not specify the method in detail, it would have been obvious to a person of ordinary skill in the art to further expand the device disclosed by Thomas with the templates as disclosed by Pak in order to allow for greater ease and reproducibility in craniotomy procedures (Pak [0006]).
Regarding claim 3, Thomas as modified by Pak discloses the device of claim 2. Pak further discloses the processor is configured to correct the selected template in accordance with a shape of the head of the subject to set the craniotomy pattern ([0017]: "After a craniotomy is made, the depth at which the drill stopped is recorded and the next craniotomy is drilled to this depth plus an offset of either 300 or 400 μm… but due to the curvature of the skull, a 300-400 μm offset is required").
Regarding claim 14, Thomas as modified by Pak discloses the device of claim 3. Pak further discloses wherein the processor is configured to correct the selected template by displacing and deforming an incision line of skin and an incision line of skull included in the selected template in accordance with the shape of the head of the subject and the start position on the surface of the brain. ([0017]: "After a craniotomy is made, the depth at which the drill stopped is recorded and the next craniotomy is drilled to this depth plus an offset of either 300 or 400 μm… but due to the curvature of the skull, a 300-400 μm offset is required", [0113]: “Next, they receive a start command. The final motor block in this frame is the “GetPosition” block. This gets the position of each motor and stores it in two local variables: position and origin. Since these motor blocks are in a while loop, as the user moves the motors the position is constantly being updated. Only after the “Done Positioning” button is pushed, do the position values get stored in the two previously mentioned local variables.”, wherein the start position may be specified per [0109]: “the buttons on the motor drivers or by entering a number for the displacement of each motor in the LabVIEW window.”).
Regarding claim 15, Thomas as modified by Pak discloses the device of claim 14. Pak further discloses shift the incision line of the skull in the selected template such that a center of a region surrounded by the shifted incision line of the skull matches the start position ([0109]: “the buttons on the motor drivers or by entering a number for the displacement of each motor in the LabVIEW window.”); and shift the incision line of the skin in the template to a position corresponding to the shifted incision line of the skull ([0113]: “they receive a start command. The final motor block in this frame is the “GetPosition” block. This gets the position of each motor and stores it in two local variables: position and origin. Since these motor blocks are in a while loop, as the user moves the motors the position is constantly being updated. Only after the “Done Positioning” button is pushed, do the position values get stored in the two previously mentioned local variables.”).
Response to Arguments
Applicant's arguments filed 12/08/2025 have been fully considered but they are not persuasive.
Applicant argues on page 9 of applicant’s remarks that the amendments of claims 1, 12, and 13 overcome the rejection under 35 U.S.C. 101. Applicant argues that pixel-wise calculations require image processing operations that exceed human cognitive capability. Applicant further argues that the claim is integrated within a specific technical solution. However, pixel based distance calculation constitutes a mathematical process. The claim language states that a distance calculation is performed from a representative point to an abnormal region. Given coordinate values for each, a distance calculation is computable with a pen and paper within the human mind. Additionally, displaying a surgical path on a model is merely reciting instructions for a surgical procedure and is thus a mental process (see MPEP 2106.04(a)(2) III. A: “a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016);”.) Therefore, the rejection with respect to claims 1-3, 5-6, and 8-15 is maintained.
With regards to the rejection of claims 1 and 4-13 under USC 102/103, Applicant argues on pages 10-11 of applicant’s remarks that Thomas fundamentally generates a path by linearly interpolating between two endpoints. However, per para [0135], and as acknowledged by remarks pg. 11, Thomas discloses the addition of intermediate positions to form a piecewise path that further follow a sulci. Additionally, per para [0103], a straight linear path from a surface to the target is the method “most surgeries currently performed presently use”, and is presented for comparison, but does not limit the disclosed path to a single linear distance. Given the three limitations presented by the applicant, (1), the path passing through an intermediate position at the bottom of a sulcus is disclosed by Thomas (see rejection above and [0135], wherein intermediate positions may be defined on a sulcus). Per (2) and (3), Thomas additionally discloses that the distance is the shortest path (see rejection above). It is unclear how points (1), (2), and (3) preclude a piece-wise linear path from being computed as no disclosed limitations specify that the calculated path cannot be linear.
With regards to the rejection of claim 3 under USC 103, applicant argues on page 12 that Pak discloses an offset for safety purposes and is therefore not a correction of a craniotomy template. However, per para [0117] of Pak, the offset of the drilling template is made due to the curvature of the skull, i.e. the shape of the user’s head. Correction of a drilling template accounting for the curvature of the user’s skull is effectively a correction of a selected template in accordance with a shape of the head of a subject and further the start position on the surface of a brain as the purpose is to prevent drilling past the surface. MPEP 2183 states that a prior art element is equivalent when (A) The prior art element performs the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification. Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sela et al. (US20170076450A1) – discloses a craniotomy simulation device including the ranking of surgical paths based on a weighted score
Lang (US 20240041530 A1) – discloses modifying a start position/incision line for a craniotomy
Shalayev (US 20190076195 A1) – discloses modifying an incision line
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791