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 on 03/16/2026 has been entered. Claims 1, 11 and 13 have been amended. Claims 1, 4-5 and 8-13 remain pending.
The previously raised objections for Claims 1 and 11 are withdrawn because the issues have been properly corrected.
The previously raised rejections under 35 U.S.C. 112(b) for Claims 1, 4-5 and 8-13 are withdrawn because the issues have been properly corrected.
Response to Arguments
On Page 9 of Remarks, Applicant argues that, regarding the amended Claims 1 and 11, the cited references, i.e. Xia, Lee, and Xia 2015, fail to disclose the claimed combination of features presently set forth, particularly the newly added features of “wherein the performing of the surgery simulation comprises: …” and “wherein the calculating of the optimal numerical values comprises: …”. This argument is moot in view of the new grounds of rejection which relies on the new combination of Xia, Lee and a new reference Xia et al (Int. J. Oral Maxillofac. Surg. 2015; 44: 1441-1450; hereafter Xia 2015 Part-2) to disclose these limitations in the claims.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Claim 1, Lines 30, 39, 54 and 58, and Claim 11, Lines 31, 40, 55 and 59, recite “x-axis”, which should be changed to “first-axis”.
Claim 1, Lines 30 and 39, and Claim 11, Lines 31 and 40, recite “z-axis”, which should be changed to “second-axis”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1, 4-5 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al. (US20200197137, hereafter Xia), in view of Lee et al. (Journal of Cranio-Maxillofacial Surgery. 44(5), 2016, 557-568; hereafter Lee) and Xia et al (Int. J. Oral Maxillofac. Surg. 2015; 44: 1441-1450; hereafter Xia 2015 Part-2).
Regarding Claim 1, Xia discloses a method of providing a surgery simulation, which is performed by one or more processors of a computing device, the method comprising:
identifying landmarks of a particular patient on a medical image of the particular patient, wherein the landmarks are anatomical points in a head of the particular patient (Xia, Para 0062; “Cephalometry, or cephalometric analysis, is a group of anatomical landmark-based measurements used to quantify deformities of the head and facial units (e.g., midface, maxilla or mandible). Traditionally, cephalometric analysis is performed two-dimensionally on a cephalogram (a 2D plain radiograph that is acquired in a calibrated condition)”);
generating three-dimensional (3D) modeling data by performing segmentation on the medical image (Xia, Para 0049; “the 3D model module can be configured for image (e.g., computed tomography (CT) or other medical image) segmentation and 3D model reconstruction”);
generating a user interface including the 3D modeling data (Xia, Fig. 1 shows the user interface of the system. In the lower-right corner of the display shows a 3D modeling data);
providing the user interface to a user terminal (Xia, Para 0049; “the composite 3D module can be displayed on a display device (e.g. output device 112 as shown in FIG. 11)”);
setting axes and reference points corresponding to the 3D modeling data based on the landmarks (Xia, Para 0022; “The computer-implemented method can include digitizing a plurality of dental landmarks on a composite three-dimensional (3D) model of a subject's dental arch, […], translating the initial Cartesian coordinate system to a new origin and assigning a first axis (z-axis) […] calculating a second axis (y-axis) […], and calculating a third axis (x-axis) of the object reference frame for the subject's dental arch”), wherein the axes comprise a first axis, a second axis, a third axis, and a fourth axis (see the disclosure of the four axes in the discussion below on the six operations);
determining an object to be moved for a surgery (Xia, Para 0015 describes in much details of identifying different objects or segments and repositioning individual segments, “the step of performing the surgical simulation can further include defining a hierarchal structure for the osteotomized segments, establishing a final dental occlusion, and repositioning the osteotomized segments into a desired maxillomandibular combination”);
performing the surgery simulation of a plurality of operations of the surgery (Xia, Para 0015; “the step of repositioning the osteotomized segments can further include translating and/or rotating the maxillomandibular combination in six degrees of freedom”), in response to user inputs received via one or more input windows of the user interface on the user terminal, wherein the plurality of operations comprise (Xia, Para 0094 describes the same sequence of translations and rotations (yaw, roll and pitch) as the application in their established reference frame, “Following the clinical protocol, surgical corrections are then performed in a specific sequence: midline correction (mediolateral correction), yaw correction, roll correction, vertical position adjustment, pitch adjustment, and finally anteroposterior position adjustment [4]”) (Xia, Para 0153-0174 describes a detailed process of determining an object (or local) reference frame, and discloses the different planes, which define the axes, and the various anatomical landmarks including U0 and U6 (Table 2)):
a first operation of moving the object (midline correction (mediolateral correction)) on the first axis (intersection of the axial and coronal planes);
a second operation of rotating the object about a first landmark (U0) of the landmarks (yaw correction) on the second axis (intersection of the midsagittal plane and the coronal plane);
a third operation of rotating the object about a second landmark (the middle point between U6-left and U6-right, or point P in Fig. 18D) of the landmarks (roll correction) on the third axis (intersection of the midsagittal plane and the axial plane or occlusal plane), which is a line segment generated based on the first landmark and the second landmark (it is noted that as the first landmark and the second landmark are both on the third axis, the rotation about the second landmark here would be equivalent to a rotation about the first landmark);
a fourth operation of moving the object on the second axis (vertical position adjustment);
a fifth operation of rotating the object by setting the first landmark (U0) as an origin of rotation and the first axis as an axis of rotation (pitch adjustment); and
a sixth operation of moving the object (anteroposterior position adjustment) on the fourth axis (the “anteroposterior” direction),
wherein (Xia, Para 0094; “The first surgical corrections (translation and rotation) are made to the maxillomandibular combination, usually around the maxillary dental midline point. Following the clinical protocol, surgical corrections are then performed in a specific sequence: midline correction (mediolateral correction), yaw correction, roll correction, vertical position adjustment, pitch adjustment, and finally anteroposterior position adjustment [4].” This disclosure of Xia not only disclose the 6 geometric translations and rotation, but also specifies that these movements are “around the maxillary dental midline point”, which corresponds to the first landmark of Application; in addition, Xia refers to reference [4], where more details are disclosed so are cited below as evidence):
the first operation comprises moving a maxilla of the head of the particular patient to a left or a right, when a face of the head of the particular patient is viewed from a front (Xia, Para 0094; “midline correction (mediolateral correction)”) (Xia, reference [4], Page 1437, Column 2, Para 3; “Transverse translation places the maxillary incisal midpoint on the midsagittal plane.”);
the second operation comprises performing z-axis rotation until an x-axis coordinate of the second landmark changes by a value, using the first landmark as a center of rotation, when the face is viewed from the front (Xia, Para 0094; “yaw correction”) (Xia, reference [4], Page 1437, Column 2, Para 3; “yaw rotation pivots the maxilla around the incisal midpoint.”);
the third operation comprises performing rotation using the second landmark as the center of rotation, when the face is viewed from the front (Xia, Para 0094; “roll correction”) (Xia, reference [4], Page 1437, Column 2, Para 3; “Roll rotation pivots the maxilla around the incisal midpoint until the right and left teeth are vertically levelled.”);
the fourth operation comprises moving the maxilla upward and downward when the face is viewed from the front (Xia, Para 0094; “vertical position adjustment”) (Xia, reference [4], Page 1437, Column 3, Para 2; “the vertical position of the maxilla is normalized. The planner translates the maxilla up or down, placing its incisal midpoint in an ideal position in relation to the upper lip stomion”);
the fifth operation comprises performing x-axis rotation until the z-axis coordinate of the second landmark changes by a value, using the first landmark as the center of rotation, when the face is viewed from the front (Xia, Para 0094; “pitch adjustment”) (Xia, reference [4], Page 1437, Column 3, Para 2; “one normalizes the maxillary pitch. The planner pivots the maxilla around the incisal midpoint until its pitch is optimized.”); and
a sixth input corresponding to the sixth operation and containing information for moving the maxilla forward and backward when the face is viewed from the front (Xia, Para 0094; “anteroposterior position adjustment”) (Xia, reference [4], Page 1438, Column 1, Para 2; “The final adjustment aligns the maxilla in an anteroposterior position.”);
generating surgery simulation result data based on the surgery simulation (Xia, Para 0050; “The surgical simulation module can be configured to perform the surgery on the osteotomized segments, e.g. by repositioning, translating, and/or rotating”) (Xia, Para 0092; “users (e.g. doctors or surgeons) can simulate the desired orthognathic surgical procedure”),
wherein the performing of the surgery simulation comprises:
analyzing 3D modeling of the particular patient (3D cephalometric analysis) to calculate optimal numerical values for corrective surgery (Xia, Para 0126; “… the true 3D cephalometric analysis [16], including the five geometric properties of orientation, symmetry, position, size and shape, is implemented in a surgical planning system for the first time. This is especially important for correctly quantifying deformities and planning treatment.”);
calculating optimal numerical values corresponding to the plurality of operations through automatic correction (Xia, Para 0156; “By comparing the object reference frame for the dental arch to the global reference frame for the whole face, the symmetrical alignment of the dental arch can be calculated as a transverse difference in the central incisal midpoint (dental midline), and orientational differences in yaw and roll (cant).” See more discussion below at “wherein the calculating”), wherein the calculated optimal numerical values are values calculated to perform an optimal surgery simulation according to a state of the head of the particular patient (Xia, Para 0075; “A cephalometric analysis report, including measurements and the transformation matrix of each landmark before and after surgical simulation, can be generated.” The disclosed “transformation matrix” comprises numerical values of various spatial operations by which a pre-surgery state can be transformed to a more desired post-surgery state); and
performing the surgery simulation on the basis of the optimal numerical values (Xia, Para 0054; “In the Surgical Simulation module 110, a surgical plan is formulated. The optimal surgery is chosen based on both visual results and mathematical calculations.”), and
wherein the calculating of the optimal numerical values comprises:
calculating a first amount of movement on an x-axis (a transverse difference in the central incisal midpoint (dental midline)) required to cause an x-axis coordinate of the first landmark (the central incisal midpoint in the object reference frame) to be the same as a midsagittal plane of a whole face (Xia, Para 0060; “… in establishing the global reference frame, is to define the midsagittal plane … the midsagittal plane should divide the head evenly into the right and left halves, acting as the plane of symmetry between them”), so as to obtain a first numerical value corresponding to the first operation (Xia, Para 0156; “By comparing the object reference frame for the dental arch to the global reference frame for the whole face, the symmetrical alignment of the dental arch can be calculated as a transverse difference in the central incisal midpoint (dental midline), and orientational differences in yaw and roll (cant).”); and
calculating a second amount of movement (orientational differences in yaw) required to cause the x-axis coordinate of the second landmark to be the same as that of the first landmark while the first numerical value is applied (symmetrical alignment of the dental arch; Xia, Para 0066, further disclose “Symmetrical alignment refers to the alignment of each facial unit with respect to the midsagittal plane of the head, in the global reference frame.” This further disclosure indicates that the disclosed “symmetrical alignment of the dental arch” would align the midsagittal plane of the dental arch (including both the first and second landmarks) to the midsagittal plane of the head or whole face) to obtain a second numerical value corresponding to the second operation (Xia, Para 0156; “By comparing the object reference frame for the dental arch to the global reference frame for the whole face, the symmetrical alignment of the dental arch can be calculated as a transverse difference in the central incisal midpoint (dental midline), and orientational differences in yaw and roll (cant).”).
Xia does not clearly and explicitly disclose:
wherein user inputs containing information of maxilla-related operations are received,
wherein a midsagittal plane of a whole face passes through a nasion, which is an intersection of a frontonasal suture and an internasal suture of the head of the particular patient, and
wherein a second amount of movement is on the x-axis.
Lee in a same field of endeavor discloses:
wherein user inputs containing information of maxilla-related operations are received (Lee, Page 559, left column; “the desired amount of displacement was entered by a surgeon using a graphical user interface (Kim et al., 2014). During surgery planning, the virtual maxillary model was displaced in 6 degrees of freedom in the same manner as used in conventional orthognathic surgery”) (Lee, Fig. 3 shows the input window on the right side of interface where user can input values to achieve “Movement” that comprises “Translation” and “Rotation”), and
wherein a second amount of movement is on the x-axis (Lee, Page 559, left column; “the amount of rotation between the target and goal points could be defined by the linear displacement between a target point and a goal position, not by an angular degree”. Here Lee discloses that the yaw rotation can be defined by a linear displacement of a point (i.e. the second landmark)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xia, as suggested by Lee, in order to receive from user six inputs corresponding to six operations and to define a rotation by linear displacement of an anatomical point. One of ordinary skill in the art would have been motivated to make the modification of receiving user inputs for the benefit of performing the surgery operations in a precise, reproducible and flexible way (Lee, Page 567, the 7th sentence of Conclusion; “The method provided accurate and flexible guidance for bimaxillary orthognathic surgery based on intraoperative visualization and quantification of deviations for simulated MMC and landmarks while minimizing inconvenience to a surgeon.”), and to make the modification of defining rotation by linear displacement for the benefit of ensuring key anatomical points being moved by desired distance or to desired positions.
Xia and Lee do not clearly and explicitly disclose wherein a midsagittal plane of a whole face passes through a nasion, which is an intersection of a frontonasal suture and an internasal suture of the head of the particular patient.
Xia 2015 Part-2 in a same field of endeavor discloses wherein a midsagittal plane of a whole face passes through a nasion, which is an intersection of a frontonasal suture and an internasal suture of the head of the particular patient (Xia 2015 Part-2, Fig. 4 shows that the nasion is in the midsagittal plane of a whole face or a global reference frame, or is used to define such a plane). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xia and Lee, as suggested by Xia 2015 Part-2, in order to include the nasion in defining a midsagittal plane of a whole face. One of ordinary skill in the art would have been motivated to make the modification for the benefit of utilizing the anatomical feature of the nasion to establish a reliable midsagittal plane for optimal surgery outcome.
Regarding Claim 4, Xia, Lee and Xia 2015 Part-2 disclose all the limitations of Claim 1 as discussed above.
Xia further discloses wherein the axes and the reference points corresponding to the 3D modeling data comprise at least one of a point, a line, or a plane generated after performing an operation related to at least one of a midpoint, an intersection, a line segment, a plane, a vertical relationship, or a parallel relationship based on the landmarks (Xia, Para 0022 describes in much details of establishing a Cartesian coordinate system based on 3D model of a subject and a plurality of dental landmarks).
Regarding Claim 5, Xia, Lee and Xia 2015 Part-2 disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the user inputs comprise at least one of an input of a numerical value designated by a user or an input of a calculated optimal numerical value.
Lee further discloses wherein the user inputs comprise at least one of an input of a numerical value designated by a user or an input of a calculated optimal numerical value (Lee, Fig. 3. and Page 559, “the desired amount of displacement was entered by a surgeon using a graphical user interface”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xia, Lee and Xia 2015 Part-2, as further suggested by Lee, in order to allow user to designate numerical value for guiding operations in surgery simulation. One of ordinary skill in the art would have been motivated to make this modification for the benefit of providing surgeon an accurate and flexible way of inputting his/her desired amount for displacements or rotations in 6 degrees of freedom (Lee, Page 559, left column; “the desired amount of displacement was entered by a surgeon using a graphical user interface […] During surgery planning, the virtual maxillary model was displaced in 6 degrees of freedom in the same manner as used in conventional orthognathic surgery”).
Regarding Claim 8, Xia, Lee and Xia 2015 Part-2 disclose all the limitations of Claim 1 as discussed above.
Xia further discloses wherein the surgery simulation result data comprises: main diagnostic index data related to at least one of postoperative 3D modeling data obtained as a result of performing the surgery simulation (Xia, Para 0096; “the initial and final position of each bony segment can be visualized and compared”); progress data indicating which operation among the plurality of operations of the surgery is being performed (Xia, Para 0035 and Figs. 7A and 7B; “the 3D cephalometry window with measurements being updated in real time during surgical simulation”; the “measurements” are listed in Para 0066-0070); or data of positions and amounts of change of the one or more landmarks as the surgery simulation is performed (Xia, Para 0074; “Report Calculated Results […] the results of the desired measurements are displayed […] and updated in real-time […] including measurements and the transformation matrix of each landmark before and after surgical simulation”).
Regarding Claim 9, Xia, Lee and Xia 2015 Part-2 disclose all the limitations of Claim 1 as discussed above.
Xia further discloses the method further comprising:
generating splint modeling data based on the 3D modeling data (Xia, Para 0050; “The surgical splint module can be configured to design a surgical splint or template for the subject.”),
wherein the generating of the splint modeling data comprises:
identifying postoperative 3D modeling data included in the surgery simulation result data (Xia, Para 0016; “the surgical splint or template can be intermediate splint for maxillary surgery with the subject's upper teeth in a desired position or for mandibular surgery with the subject's lower teeth in a desired position”) (Xia, Para 0100; “Once the type of splint is selected, the upper and lower dental arches are automatically moved to the correct position for the intended type of surgery. For maxillary surgery first, the upper dental arch is displayed at its final position, while the lower dental arch is at its original position. The opposite is true for mandibular surgery first. For the final splint, both dental arches are displayed at their final positions.); and
generating the splint modeling data based on the postoperative 3D modeling data (Xia, Para 0104 describes the design of splint model based on 3D modeling data; “… digitize three landmarks on the occlusal surface of the upper dental arch to form a top plane for the splint. […] create a top contour 802 for the top face of the splint by manually tracing the upper dental arch onto top plane using a cardinal spline as shown in FIG. 8A.”) (Xia, Fig. 8A and 8B illustrate the design of splint on the basis of 3D modeling data).
Regarding Claim 10, Xia, Lee and Xia 2015 Part-2 disclose all the limitations of Claim 1 as discussed above.
Xia further discloses an apparatus comprising:
a memory storing one or more instructions (system memory 1104 in Fig. 11); and
a processor (processing unit 1106 in in Fig. 11) configured to execute the one or more instructions stored in the memory, wherein the processor executes the one or more instructions to perform the method of surgery simulation (Xia, Para 0129; “Referring to FIG. 11, an example computing device 1100 upon which embodiments of the invention may be implemented is illustrated”).
Regarding Claim 11, Xia discloses a non-transitory computer-readable recording medium on which a program for executing a method of providing a surgery simulation in conjunction with a computing device is recorded (Xia, Para 0129; “the methods and apparatuses of the presently disclosed subject matter, or certain aspects or portions thereof, may take the form of program code (i.e., instructions) embodied in tangible media, such as […] any other machine-readable storage medium wherein, when the program code is loaded into and executed by a machine, such as a computing device, the machine becomes an apparatus for practicing the presently disclosed subject matter”), wherein the method comprises:
identifying landmarks of a particular patient on a medical image of the particular patient, wherein the landmarks are anatomical points in a head of the particular patient (Xia, Para 0062; “Cephalometry, or cephalometric analysis, is a group of anatomical landmark-based measurements used to quantify deformities of the head and facial units (e.g., midface, maxilla or mandible). Traditionally, cephalometric analysis is performed two-dimensionally on a cephalogram (a 2D plain radiograph that is acquired in a calibrated condition)”);
generating three-dimensional (3D) modeling data by performing segmentation on the medical image (Xia, Para 0049; “the 3D model module can be configured for image (e.g., computed tomography (CT) or other medical image) segmentation and 3D model reconstruction”);
generating a user interface including the 3D modeling data (Xia, Fig. 1 shows the user interface of the system. In the lower-right corner of the display shows a 3D modeling data);
providing the user interface to a user terminal (Xia, Para 0049; “the composite 3D module can be displayed on a display device (e.g. output device 112 as shown in FIG. 11)”);
setting axes and reference points corresponding to the 3D modeling data based on the landmarks (Xia, Para 0022; “The computer-implemented method can include digitizing a plurality of dental landmarks on a composite three-dimensional (3D) model of a subject's dental arch, […], translating the initial Cartesian coordinate system to a new origin and assigning a first axis (z-axis) […] calculating a second axis (y-axis) […], and calculating a third axis (x-axis) of the object reference frame for the subject's dental arch”), wherein the axes comprise a first axis, a second axis, a third axis, and a fourth axis (see the disclosure of the four axes in the discussion below on the six operations);
determining an object to be moved for a surgery (Xia, Para 0015 describes in much details of identifying different objects or segments and repositioning individual segments, “the step of performing the surgical simulation can further include defining a hierarchal structure for the osteotomized segments, establishing a final dental occlusion, and repositioning the osteotomized segments into a desired maxillomandibular combination”);
performing the surgery simulation of a plurality of operations of the surgery (Xia, Para 0015; “the step of repositioning the osteotomized segments can further include translating and/or rotating the maxillomandibular combination in six degrees of freedom”), in response to user inputs received via one or more input windows of the user interface on the user terminal, wherein the plurality of operations comprise (Xia, Para 0094 describes the same sequence of translations and rotations (yaw, roll and pitch) as the application in their established reference frame, “Following the clinical protocol, surgical corrections are then performed in a specific sequence: midline correction (mediolateral correction), yaw correction, roll correction, vertical position adjustment, pitch adjustment, and finally anteroposterior position adjustment [4]”) (Xia, Para 0153-0174 describes a detailed process of determining an object (or local) reference frame, and discloses the different planes, which define the axes, and the various anatomical landmarks including U0 and U6 (Table 2)):
a first operation of moving the object (midline correction (mediolateral correction)) on the first axis (intersection of the axial and coronal planes);
a second operation of rotating the object about a first landmark (U0) of the landmarks (yaw correction) on the second axis (intersection of the midsagittal plane and the coronal plane);
a third operation of rotating the object about a second landmark (the middle point between U6-left and U6-right, or point P in Fig. 18D) of the landmarks (roll correction) on the third axis (intersection of the midsagittal plane and the axial plane or occlusal plane), which is a line segment generated based on the first landmark and the second landmark (it is noted that as the first landmark and the second landmark are both on the third axis, the rotation about the second landmark here would be equivalent to a rotation about the first landmark);
a fourth operation of moving the object on the second axis (vertical position adjustment);
a fifth operation of rotating the object by setting the first landmark (U0) as an origin of rotation and the first axis as an axis of rotation (pitch adjustment); and
a sixth operation of moving the object (anteroposterior position adjustment) on the fourth axis (the “anteroposterior” direction),
wherein (Xia, Para 0094; “The first surgical corrections (translation and rotation) are made to the maxillomandibular combination, usually around the maxillary dental midline point. Following the clinical protocol, surgical corrections are then performed in a specific sequence: midline correction (mediolateral correction), yaw correction, roll correction, vertical position adjustment, pitch adjustment, and finally anteroposterior position adjustment [4].” This disclosure of Xia not only disclose the 6 geometric translations and rotation, but also specifies that these movements are “around the maxillary dental midline point”, which corresponds to the first landmark of Application; in addition, Xia refers to reference [4], where more details are disclosed so are cited below as evidence):
the first operation comprises moving a maxilla of the head of the particular patient to a left or a right, when a face of the head of the particular patient is viewed from a front (Xia, Para 0094; “midline correction (mediolateral correction)”) (Xia, reference [4], Page 1437, Column 2, Para 3; “Transverse translation places the maxillary incisal midpoint on the midsagittal plane.”);
the second operation comprises performing z-axis rotation until an x-axis coordinate of the second landmark changes by a value, using the first landmark as a center of rotation, when the face is viewed from the front (Xia, Para 0094; “yaw correction”) (Xia, reference [4], Page 1437, Column 2, Para 3; “yaw rotation pivots the maxilla around the incisal midpoint.”);
the third operation comprises performing rotation using the second landmark as the center of rotation, when the face is viewed from the front (Xia, Para 0094; “roll correction”) (Xia, reference [4], Page 1437, Column 2, Para 3; “Roll rotation pivots the maxilla around the incisal midpoint until the right and left teeth are vertically levelled.”);
the fourth operation comprises moving the maxilla upward and downward when the face is viewed from the front (Xia, Para 0094; “vertical position adjustment”) (Xia, reference [4], Page 1437, Column 3, Para 2; “the vertical position of the maxilla is normalized. The planner translates the maxilla up or down, placing its incisal midpoint in an ideal position in relation to the upper lip stomion”);
the fifth operation comprises performing x-axis rotation until the z-axis coordinate of the second landmark changes by a value, using the first landmark as the center of rotation, when the face is viewed from the front (Xia, Para 0094; “pitch adjustment”) (Xia, reference [4], Page 1437, Column 3, Para 2; “one normalizes the maxillary pitch. The planner pivots the maxilla around the incisal midpoint until its pitch is optimized.”); and
a sixth input corresponding to the sixth operation and containing information for moving the maxilla forward and backward when the face is viewed from the front (Xia, Para 0094; “anteroposterior position adjustment”) (Xia, reference [4], Page 1438, Column 1, Para 2; “The final adjustment aligns the maxilla in an anteroposterior position.”);
generating surgery simulation result data based on the surgery simulation (Xia, Para 0050; “The surgical simulation module can be configured to perform the surgery on the osteotomized segments, e.g. by repositioning, translating, and/or rotating”) (Xia, Para 0092; “users (e.g. doctors or surgeons) can simulate the desired orthognathic surgical procedure”),
wherein the performing of the surgery simulation comprises:
analyzing 3D modeling of the particular patient (3D cephalometric analysis) to calculate optimal numerical values for corrective surgery (Xia, Para 0126; “… the true 3D cephalometric analysis [16], including the five geometric properties of orientation, symmetry, position, size and shape, is implemented in a surgical planning system for the first time. This is especially important for correctly quantifying deformities and planning treatment.”);
calculating optimal numerical values corresponding to the plurality of operations through automatic correction (Xia, Para 0156; “By comparing the object reference frame for the dental arch to the global reference frame for the whole face, the symmetrical alignment of the dental arch can be calculated as a transverse difference in the central incisal midpoint (dental midline), and orientational differences in yaw and roll (cant).” See more discussion below at “wherein the calculating”), wherein the calculated optimal numerical values are values calculated to perform an optimal surgery simulation according to a state of the head of the particular patient (Xia, Para 0075; “A cephalometric analysis report, including measurements and the transformation matrix of each landmark before and after surgical simulation, can be generated.” The disclosed “transformation matrix” comprises numerical values of various spatial operations by which a pre-surgery state can be transformed to a more desired post-surgery state); and
performing the surgery simulation on the basis of the optimal numerical values (Xia, Para 0054; “In the Surgical Simulation module 110, a surgical plan is formulated. The optimal surgery is chosen based on both visual results and mathematical calculations.”), and
wherein the calculating of the optimal numerical values comprises:
calculating a first amount of movement on an x-axis (a transverse difference in the central incisal midpoint (dental midline)) required to cause an x-axis coordinate of the first landmark (the central incisal midpoint in the object reference frame) to be the same as a midsagittal plane of a whole face (Xia, Para 0060; “… in establishing the global reference frame, is to define the midsagittal plane … the midsagittal plane should divide the head evenly into the right and left halves, acting as the plane of symmetry between them”), so as to obtain a first numerical value corresponding to the first operation (Xia, Para 0156; “By comparing the object reference frame for the dental arch to the global reference frame for the whole face, the symmetrical alignment of the dental arch can be calculated as a transverse difference in the central incisal midpoint (dental midline), and orientational differences in yaw and roll (cant).”); and
calculating a second amount of movement (orientational differences in yaw) required to cause the x-axis coordinate of the second landmark to be the same as that of the first landmark while the first numerical value is applied (symmetrical alignment of the dental arch; Xia, Para 0066, further disclose “Symmetrical alignment refers to the alignment of each facial unit with respect to the midsagittal plane of the head, in the global reference frame.” This further disclosure indicates that the disclosed “symmetrical alignment of the dental arch” would align the midsagittal plane of the dental arch (including both the first and second landmarks) to the midsagittal plane of the head or whole face) to obtain a second numerical value corresponding to the second operation (Xia, Para 0156; “By comparing the object reference frame for the dental arch to the global reference frame for the whole face, the symmetrical alignment of the dental arch can be calculated as a transverse difference in the central incisal midpoint (dental midline), and orientational differences in yaw and roll (cant).”).
Xia does not clearly and explicitly disclose:
wherein user inputs containing information of maxilla-related operations are received,
wherein a midsagittal plane of a whole face passes through a nasion, which is an intersection of a frontonasal suture and an internasal suture of the head of the particular patient, and
wherein a second amount of movement is on the x-axis.
Lee in a same field of endeavor discloses:
wherein user inputs containing information of maxilla-related operations are received (Lee, Page 559, left column; “the desired amount of displacement was entered by a surgeon using a graphical user interface (Kim et al., 2014). During surgery planning, the virtual maxillary model was displaced in 6 degrees of freedom in the same manner as used in conventional orthognathic surgery”) (Lee, Fig. 3 shows the input window on the right side of interface where user can input values to achieve “Movement” that comprises “Translation” and “Rotation”), and
wherein a second amount of movement is on the x-axis (Lee, Page 559, left column; “the amount of rotation between the target and goal points could be defined by the linear displacement between a target point and a goal position, not by an angular degree”. Here Lee discloses that the yaw rotation can be defined by a linear displacement of a point (i.e. the second landmark)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xia, as suggested by Lee, in order to receive from user six inputs corresponding to six operations and to define a rotation by linear displacement of an anatomical point. One of ordinary skill in the art would have been motivated to make the modification of receiving user inputs for the benefit of performing the surgery operations in a precise, reproducible and flexible way (Lee, Page 567, the 7th sentence of Conclusion; “The method provided accurate and flexible guidance for bimaxillary orthognathic surgery based on intraoperative visualization and quantification of deviations for simulated MMC and landmarks while minimizing inconvenience to a surgeon.”), and to make the modification of defining rotation by linear displacement for the benefit of ensuring key anatomical points being moved by desired distance or to desired positions.
Xia and Lee do not clearly and explicitly disclose wherein a midsagittal plane of a whole face passes through a nasion, which is an intersection of a frontonasal suture and an internasal suture of the head of the particular patient.
Xia 2015 Part-2 in a same field of endeavor discloses wherein a midsagittal plane of a whole face passes through a nasion, which is an intersection of a frontonasal suture and an internasal suture of the head of the particular patient (Xia 2015 Part-2, Fig. 4 shows that the nasion is in the midsagittal plane of a whole face or a global reference frame, or is used to define such a plane). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xia and Lee, as suggested by Xia 2015 Part-2, in order to include the nasion in defining a midsagittal plane of a whole face. One of ordinary skill in the art would have been motivated to make the modification for the benefit of utilizing the anatomical feature of the nasion to establish a reliable midsagittal plane for optimal surgery outcome.
Regarding Claim 12, Xia and Lee disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the landmarks comprise two or more of an anterior nasal spine (ANS) of a maxillary bone, an upper 1 crown point (U1CP) of a front tooth of an upper jaw, an orbitale, and a porion of the particular patient.
Xia 2015 Part-2 in the same field of endeavor discloses wherein the landmarks comprise two or more of an anterior nasal spine (ANS) of a maxillary bone, an upper 1 crown point (U1CP) of a front tooth of an upper jaw, an orbitale, and a porion of the particular patient (Xia 2015 Part-2, Page 1442, Column 3, Para 1; “… the Frankfort horizontal. Four points define this plane: right orbitale, left orbitale, right porion, and left porion.”; Page 1444, Column 2, Para 2; “the anteroposterior position of the maxilla has been measured at the anterior nasal spine (ANS), point A, and the upper incisal midpoint.”; ). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xia, Lee and Xia 2015 Part-2, as further suggested by Xia 2015 Part-2, in order to identify the listed anatomical landmarks. One of ordinary skill in the art would have been motivated to make the modification for the benefit of establishing the reference frame in a simple and widely used way (Xia 2015 Part-2, Page 1442, right column, first paragraph; “The anatomical landmark method is simple if the face has perfect symmetry. The Frankfort horizontal is constructed using both porions and both orbitales.”).
Regarding Claim 13, Xia, Lee and Xia 2015 Part-2 disclose all the limitations of Claim 1 as discussed above.
Xia further discloses wherein the first axis is an x-axis (intersection of the axial and coronal planes), the second axis is a z-axis (intersection of the midsagittal plane and the coronal plane), the first landmark is a midpoint between a right maxillary central incisor and a left maxillary central incisor to be cut (U0), the second landmark is a center of a line segment connecting a front cusp adjacent to cheeks to a first molar teeth in right and left directions (U6), and the fourth axis is a y-axis (the “anteroposterior” direction) (Xia, Para 0153-0174 describes a detailed process of determining an object (or local) reference frame, and discloses the different planes, which define the axes, and the various anatomical landmarks including U0 and U6 (Table 2)).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.Z./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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