FDETAILED 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
This Office Action is in response to Applicant’s amendment/response filed on 08/18/2025, which has been entered and made of record.
Claims 3, 9, and 10 have been cancelled.
Claims 21 and 22 have been added.
Claims 1-2, 4-8, and 11-22 are pending in the application.
Objections regarding the Drawings have been withdrawn.
The rejections to claim 7 and 8 under 35 U.S.C. 112(b) have been withdrawn.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 20 regarding the newly-added “designing, based on the first skeleton image, a first guidance for cutting a skeleton corresponding to the first area to be cut from the patient's skeleton; designing a plurality of fixing parts for fixing an actual skeleton to be cut corresponding to the first area to be cut in contact with the patient's skeleton; and designing perforated holes for screw insertion on surfaces of some of the plurality of fixing parts,” and “wherein the specifying of the first spatial information includes: generating one or more planes penetrating through the first skeleton image; selecting a specific closed area corresponding to the first area to be cut from among one or more closed areas defined in the first skeleton image by the one or more planes; and determining, as the first spatial information, a set of coordinates specified on at least two cut surfaces of the specific closed area.” limitations are fully considered but are moot in view of the new grounds of rejection represented in this Office Action.
In regards to the limitation of “wherein the specifying of the first spatial information includes: generating one or more planes penetrating through the first skeleton image; selecting a specific closed area corresponding to the first area to be cut from among one or more closed areas defined in the first skeleton image by the one or more planes; and determining, as the first spatial information, a set of coordinates specified on at least two cut surfaces of the specific closed area.”
Applicant states:
The cited references “generate a cutting surface based on the cutting line” while the “claimed subject matter creates a more complex cutting surface, thereby minimizing the cutting site”. (Remarks Page 11)
“Chiou discloses generating a cut plane or a cut line to fit the implant position, and there is no disclosure related to a cut surface of complex shape as multiple coordinate sets. In Chiou, the method fits the shape of the implant, but does not define the shape itself as a coordinate set. In Numajiri, a cutting area is set based on the reference point on the edge of the osteophytes. This is a reference point for a line or a simple plane, but does not define the shape itself using a set of coordinates on multiple cut surface.” (Remarks Page 11).
“By contrast, the claimed subject matter has the features of designating coordinates on two or more cut surfaces and forming a complex cut surface shape based on those coordinates, and thus, the claimed subject matter distinguishes over the cited references, which merely disclose simple cutting line or cutting plane-based design.” (Remarks Pages 11-12).
Examiner respectfully disagrees and believes that the combination of Chiou and Numajiri would teach the limitation cited above. Examiner will first note that the claimed subject matter simply describes generating cut planes, selecting a closed area defined by the planes, and determining coordinates on the surfaces of the closed area. Although these limitations can allow for the forming of “complex cut surface shape”, there is no limitation that the cut surface must have a complex shape. Thus, for example, even simply having two cut planes defining a closed cutting area would be sufficient to correspond to the broadest reasonable interpretation of this limitation.
Numajiri in Page 2 Section “Virtual osteotomy” reciting, “Using Blende software, we planned the areas for segmented osteotomy of the mandible using 3D mandibular bone. The planes for the osteotomy were set to both edges of the osteotomized area. The areas of the osteotomy were to have 1 or more reference points as Go and T.”
Numajiri in Page 3 Fig. 2A and 2B shows osteotomy planes (cut planes) that define a closed cutting area.
Note, even though the area to be cut is has already been planned using a software such as blender and the planes are simply generated at the edges of the planned area, one of ordinary skill in the art can still see that the planes encloses the area to be cut. The intent regarding the function of the planes is not relevant as the claimed subject matter simply describes generating cut planes and selecting an area enclosed by the planes. Numajiri does just that, planes are generated and the area enclosed by them are cut. Lastly, Numajiri does include reference points on the area to be cut, and having those points be on a coordinate system would be obvious to implement.
Chiou Col 193 Lines 10-16, “The virtual active zone . . . can be at a predetermined position, predetermined orientation and/or predetermined position and/or orientation for an intended bone cut or bone removal for an implant component”
Chiou Col 194 Lines 6-14, “A predetermined position, predetermined orientation and/or predetermined position and/or orientation of the virtual active zone . . . can be derived using any of the foregoing information including the coordinates of a bone cut or bone removal.”)
Chiou in Col 193 Lines 10-16 describes an example of a “virtual active zone” being at a predetermined position/orientation for an intended bone cut / bone removal for an implant. Then in Col 194 Lines 6-14, Chiou describes deriving the predetermined position/orientation of the virtual active zone using coordinates of a bone cut or bone removal.
In this case, Chiou additionally supplements Numajiri reinforcing the idea of a bone cut area which is defined by coordinates.
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 Lines 13-14 recites, “specify first spatial information on a second area to be implanted in the second skeleton image; and” should be “specify second spatial information on a second area to be implanted in the second skeleton image; and”. This is based on the fact that Claim 1 recites, “specifying second spatial information on a second area . . .” Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 7, 11, 14, 16, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chiou et al. (US 12211151 B1) (Hereinafter referred to as Chiou) in view of Numajiri et al. (“Low-cost Design and Manufacturing of Surgical Guides for Mandibular Reconstruction Using a Fibula”, Hereinafter referred to as Numajiri).
Regarding Claim 1, Chiou discloses, A method performed by an apparatus for designing a patient-specific implant and guidance, the method comprising: (Abstract reciting, “systems, devices and methods for performing a surgical step or surgical procedure”)
specifying a first skeleton image of a first part of a patient's skeleton, wherein the first part includes a region where a graft material is to be implanted; (See Col 2 Lines 37-45, “generate a 3D stereoscopic display by the see through optical head mounted display of a first surface and a second surface, wherein the first surface is a surface of an anatomic structure”
See Col 41 Lines 1-5, “a 3D model and/or 3D surfaces generated from or derived from an x-ray or multiple x-rays, e.g. using bone morphing technologies, as described in the specification or known in the art.”
Lastly see, Col 193 Lines 10-16, “The virtual active zone . . . can be at a predetermined position, predetermined orientation and/or predetermined position and/or orientation for an intended bone cut or bone removal for an implant component”)
modeling an implant that includes the graft material; (Col 2 Lines 37-47 reciting, “generate a 3D stereoscopic display by the see through optical head mounted display of a first surface and a second surface, wherein the first surface is a surface of an anatomic structure, wherein the second surface is a surface of a virtual surgical guide, a virtual tool, a virtual instrument, a virtual implant, a virtual device, or combinations thereof. . .”)
specifying first spatial information on a first area to be cut in the first skeleton image; (Col 2 Line 48, “wherein the first surface is registered in a coordinate system”; Also see Col 192 Lines 18-26, “The one or more optical head mounted displays can be registered in a coordinate system, e.g. a common coordinate system. . . The virtual active zone . . . can be registered in the same coordinate system.”
Lastly, see Col 194 Lines 6-14, “A predetermined position, predetermined orientation and/or predetermined position and/or orientation of the virtual active zone . . . can be derived using any of the foregoing information including the coordinates of a bone cut or bone removal.”)
specifying second spatial information on a second area to be implanted in the second skeleton image; and (Col 2 Lines 49-50, “wherein the second surface is registered in the coordinate system”; further Col 232 Lines 34-38, “The virtual implant can be registered and/or displayed in relationship to a common coordinate system.”)
overlapping the second skeleton image and the first skeleton image by matching the first spatial information with the second spatial information. (Col 40 Lines 63-67, “ In embodiments, one or more 3D models and/or 3D surfaces generated. . . superimposed with and/or aligned with one or more 3D models and/or 3D surfaces generated by another imaging test”; further Col 45 Lines 26-31, “Any surface matching algorithm known in the art can be utilized to register overlapping surface areas and thereby transform all surface portions into the same coordinate space, for example the Iterative Closest Point method described in Besl et al.”
Lastly, see Col 19 Lines 33-39, “In some embodiments, the one or more coordinates from the graphical representation of the implant or prosthesis in the coordinate system after the moving and aligning are used to determine one or more of a location, orientation, or alignment or coordinates of a bone removal for placing the implant or prosthesis.”)
designing, based on the first skeleton image, a first guidance for cutting a skeleton corresponding to the first area to be cut from the patient's skeleton; (Col 223 Lines 45-49 reciting, “FIGS. 14A-D provide an illustrative, non-limiting example of the use of virtual surgical guides such as a distal femoral cut block displayed by an optical see through head mounted display (OHMD) and physical surgical guides such as physical distal femoral cut blocks. Also See Fig. 14A – 14D showing a surgical guidance on a bone.)
designing a surgical guide for fixing an actual skeleton to be cut corresponding to the first area to be cut in contact with the patient's skeleton; and (Col 229 Lines 29-34 reciting, “In some embodiments, a physical and a corresponding virtual proximal tibial guide or a physical and a corresponding virtual distal femoral guide can also be pin guides, wherein the physical guide can be used to place two or more pins in the bone for attaching physical cut guides for subsequent surgical steps. Also see Figs 17A – 17F.)
designing perforated holes for screw insertion on surfaces of the surgical guide, (See Fig. 14C which shows holes for pins on the surgical guide. Note that although Chiou teaches to use pins and not explicitly screws for these holes, it obvious to one of ordinarily skill in the art to also use screws as both screws and pins serve a similar function of fixing the surgical guide in place.)
wherein the specifying of the first spatial information includes: generating one or more planes penetrating through the first skeleton image; (Col 124 Lines 1-2 reciting, “A 2D or 3D display can also include multiple cut planes, e.g. two or more femoral neck cuts in a hip replacement procedure”)
selecting a specific closed area corresponding to the first area to be cut; and (See Col 193 Lines 10-16, “The virtual active zone . . . can be at a predetermined position, predetermined orientation and/or predetermined position and/or orientation for an intended bone cut or bone removal for an implant component”
Also see Col 194 Lines 6-14, “A predetermined position, predetermined orientation and/or predetermined position and/or orientation of the virtual active zone . . . can be derived using any of the foregoing information including the coordinates of a bone cut or bone removal.”)
determining, as the first spatial information, a set of coordinates specified on at least two cut surfaces of the specific closed area. (See Col 194 Lines 6-14 describing deriving the predetermined position/orientation of the virtual active zone using coordinates of a bone cut or bone removal.
Also see Col 182 Lines 18-28 reciting, “The predetermined virtual surgical plan can be generated. . . by utilizing one or more coordinates of the virtually placed virtual implant component; and/or by deriving the plane and/or coordinates of the bone cut surface or plane using the virtually placed implant component, including its coordinates and geometry, including the geometry of a planar surface of the implant facing the bone cut.”)
However, Chiou fails to explicitly disclose modeling a second skeleton image of a second part of the patient's skeleton, wherein the second part is different from the first part and includes the graft material;
designing a plurality of fixing parts for fixing an actual skeleton to be cut corresponding to the first area to be cut in contact with the patient's skeleton; and
designing perforated holes for screw insertion on surfaces of some of the plurality of fixing parts
selecting a specific closed area corresponding to the first area to be cut from among one or more closed areas defined in the first skeleton image by the one or more planes; and
Numajiri teaches modeling a second skeleton image of a second part of the patient's skeleton, wherein the second part is different from the first part and includes the graft material; (See Fig. 2C for display of Fibula Bone (2nd Skeleton Image with graft material). Note that the first skeleton image is of the mandible as shown partially in the background of Fig. 2C and displayed in Figs. 2A and 2B.)
designing a plurality of fixing parts for fixing an actual skeleton to be cut corresponding to the first area to be cut in contact with the patient's skeleton; and (See Figs. 5A, 5B, 6A and 6E showing a first guidance based on the first skeleton image which has a plurality of fixing parts at the ends attached to the first skeleton (mandible) around the area to be cut.)
designing perforated holes for screw insertion on surfaces of some of the plurality of fixing parts (Although the figures in Numajiri’s do not explicitly show holes for screws, Chiou already teaching the idea of holes for pins on the surgical guide. In combination with Numajiri, the holes would be on the surface of some of the plurality of fixing parts.)
selecting a specific closed area corresponding to the first area to be cut from among one or more closed areas defined in the first skeleton image by the one or more planes; and (Page 2 Section “Virtual osteotomy” reciting, “Using Blende software, we planned the areas for segmented osteotomy of the mandible using 3D mandibular bone. The planes for the osteotomy were set to both edges of the osteotomized area. The areas of the osteotomy were to have 1 or more reference points as Go and T.” Lastly, see Page 3 Fig. 2A and 2B shows osteotomy planes (cut planes) that define a closed cutting area.
Note, even though the area to be cut is has already been planned using a software such as blender and the planes are simply generated at the edges of the planned area, one of ordinary skill in the art can still see that the planes encloses the area to be cut. The intent regarding the function of the planes is not relevant as the claimed subject matter simply describes generating cut planes and selecting an area enclosed by the planes. Numajiri does just that, planes are generated and the area enclosed by them are cut.)
Numajiri additionally teaches designing a first guidance for cutting a skeleton corresponding to the area to be cut from the patient's skeleton. (See Figs. 5A, 5B, 6A and 6E showing a first guidance based on the first skeleton image.)
determining, as the first spatial information, a set of coordinates specified on at least two cut surfaces of the specific closed area. (See Figs. 5A, 5B, 6A and 6E teaching reference points Go and T on the area of bone cut.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiou with Numajiri such that the virtual implant modeled is another skeleton image with graft material (Fibula Bone) as well as selecting a closed area enclosed by cut planes for bone removal.
The motivation to combine Chiou with Numajiri would have been to maximize good outcomes for patients. Numajiri recites “When the fibular flap is planned, it is very important to decide where the mandible should be osteotomized, where the fibula should be cut, and how accurately the surgery should be performed. These are often decided based on the presurgical plan to try to maximize good outcomes for patients.”
Regarding Claim 2, Chiou in view of Numajiri discloses, The method of claim 1, wherein the specifying of the first skeleton image includes: modeling a skeleton combination image including a plurality of skeleton images adjacent to each other; (See Chiou Col 41 Lines 1-5 reciting, “a 3D model and/or 3D surfaces generated from or derived from an x-ray or multiple x-rays, e.g. using bone morphing technologies, as described in the specification or known in the art.” Further see Col 49 Lines 57-58 reciting, “the HMD can display a virtual image of a target tissue or adjacent tissue.” Lastly, see Col 170 Lines 3-24 reciting, “In some embodiments, the 2D x-rays images can be used to derive information about the dimensions and shape of the anatomic structure(s) included in the x-ray. . . information from multiple x-rays images obtained with different projection or beam angles is combined or aggregated”)
in a plane penetrating through the skeleton combination image which is movable along a specific axis, specifying a position of the plane on the specific axis ; and (Chiou in Col 3 Lines 22-25 reciting, “In some embodiments, the virtual surgical guide comprises a virtual cut guide, a virtual plane, a virtual cut plane, a virtual saw blade, virtual axis or combinations thereof.” Further see Col 67 Line 64 – Col 68 Line 12 reciting, “In addition to virtual planes, the surgeon can place one or more virtual points . . . By identifying two or more virtual points the surgeon can define a virtual axis or vector.” Further see Col 124 Lines 37-38 reciting, “a virtual interface displayed by the HMD display, e.g. a finger slider or finger tab to move and/or rotate a virtual cut plane by virtually touching it.” Note that there exists a scenario in which the surgeon moves the virtual cut plane along a specific axis. The surgeon can move the plane using an interface and the surgeon can define a specific axis, so it would be possible for the plane to be moved along that specific axis. Similarly, the surgeon can also specify a position of the plane in the specific axis since they have the ability to move the plane to the position that they desire.)
specifying, as the first skeleton image, a skeleton image penetrating through the plane whose position on the specific axis is specified, among the plurality of skeleton images included in the skeleton combination image. (Chiou teaches specifying a virtual cut plane and its position on the specific axis as well as deriving a 3d model from multiple x-rays (skeleton images) as well as combining those images. See Fig 4. Showing a bone with a cut plane. Also see Figs. 4B and 4C.)
Regarding Claim 4, Chiou in view of Numajiri discloses wherein the specifying of the second spatial information includes determining, as the second spatial information, a set of coordinates specified by a number corresponding to the number of coordinates included in the first spatial information on the second skeleton image. (Chiou in Col 45 Lines 26-31 reciting, “Any surface matching algorithm known in the art can be utilized to register overlapping surface areas and thereby transform all surface portions into the same coordinate space, for example the Iterative Closest Point method described in Besl et al.” Note that Iterative Closest Point method is used to minimize the difference between two clouds of points (implying there are an equal corresponding set of points between the first and second surfaces).
Also see Numajiri teaching “1 or more reference points as Go and T” on the area of bone cut. Further in Numajiri Page 5 Section “Measurement” reciting, “To evaluate the accuracy of the reconstructions, the distances between reference points (C1-C1, C1-Go, G—T, T-T, and so on) were calculated.” Once again implying and explicitly stating an equal set of points. The motivation to combine would have been same as that of Claim 1 rejections.)
Regarding Claim 5, Chiou in view of Numajiri discloses The method of claim 1, wherein the overlapping includes moving the second skeleton image by a difference between each coordinate included in the first spatial information and each coordinate included in the second spatial information. (Chiou teaches using the Iterative Closest Point method that minimizing the distance between two sets of points. Further see Col 40 Lines 63-67 reciting, “ In embodiments, one or more 3D models and/or 3D surfaces generated. . . superimposed with and/or aligned with one or more 3D models and/or 3D surfaces generated by another imaging test.”
Numajiri Page 5 Section “Measurement” reciting, “To evaluate the accuracy of the reconstructions, the distances between reference points (C1-C1, C1-Go, G—T, T-T, and so on) were calculated.” As shown, the taking the difference between coordinates of the first and second spatial information is taught. The motivation to combine would have been same as that of Claim 1 rejections.)
Regarding Claim 7, Chiou in view of Numajiri discloses The method of claim 1, further comprising: specifying, as the second area to be implanted, an area overlapping the first area to be cut among the second skeleton images overlapping the first skeleton image. (Chiou discloses “virtual active zone” as the area to be cut. Further see Col 196 Lines 22-27 reciting, “The surgical plan can also include virtual surgical guides, e.g. virtual cut guides, virtual axes, virtual cut planes. Areas or portions of bone to be resected, removed, cut or milled can be highlighted in the virtual model, for example in a different color.”
Then Numajiri discloses cutting the fibula (second skeleton image) based on the area defined by the cut planes and shows it overlapping the first skeleton image in Figs. 2C, 2D, and 2E. The motivation to combine would have been same as that of Claim 1 rejections.)
Regarding Claim 11, Chiou in view of Numajiri discloses The method of claim 1, wherein the designing of the plurality of fixing parts includes: designing a first sub-fixing unit that is in contact with a cut surface of the first area to be cut and orthogonal to a plane defining the area to be cut; and designing a second sub-fixing unit that is in contact with the cut surface of the first area to be cut and orthogonal to the first sub-fixing unit. (Numajiri see Figs. 5A and 5D showing first and second subfixing ends attached with a handle between. See Fig. 3D showing first and second subfixing ends attached to mandible (first skeleton image) around the area to be cut and orthogonal to the plane defining the area to be cut with the second sub fixing unit being orthogonal to the first. Also see Figs. 6A and 6D showing the first guidance 3d printed. The motivation to combine would have been same as that of Claim 1 rejections.)
Regarding Claim 14, Chiou in view of Numajiri discloses The method of claim 1, wherein the designing of the first guidance further includes designing a handle part connecting the plurality of fixing parts. (See Numajiri Fig. 3E showing pillars connecting the subfixing parts. The motivation to combine would have been same as that of Claim 1 rejections.)
Regarding Claim 16, Chiou in view of Numajiri discloses The method of claim 1, further comprising: based on the second skeleton image, designing a second guidance for cutting the graft material from another bone of the patient’s skeleton. (Numajiri See Fig. 4 and Fig. 6B and 6C showing second guidance on fibula bone (another bone of the patient’s skeleton) for cutting graft material. The motivation to combine would have been same as that of Claim 1 rejections.)
Regarding Claim 17, Chiou in view of Numajiri discloses The method of claim 16, wherein the designing of the second guidance includes designing the second guidance by excluding an area of a partially overlapping second skeleton image from a hexahedron partially overlapping the second skeleton image. (Numajiri see Fig. 4. Also see Page 2 Section “Guides design” reciting, “For the fibula (Fig. 4) because the osteotomy planes were set in even numbers, each pair of planes was connected to make a solid, and the fibular bone solid was subtracted from these solids. The remaining solids and a prop to connect them were united to make a fibular jib.” Fig. 4 Description also describes a “box-shaped solid” formed by connecting the cut planes and how the solid is subtracted (excluded) based on the structure of the skeleton. A box would be polygon with six sides and is thus be considered a hexahedron. The motivation to combine would have been similar to that of Claim 1 rejection motivation.)
Regarding Claim 19, Chiou in view of Numajiri discloses A non-transitory computer-readable recording medium on which a program for performing the method according to claim 1 is recorded. (Chiou in Col 48 Lines 43-48 reciting, “For purposes of registration of virtual data and live data, the HMD can be optionally placed in a fixed position, e.g. mounted on a stand or on a tripod. While the HMD is placed in the fixed position, live data can be viewed by the surgeon and they can be, optionally recorded with a camera and/or displayed on a monitor.” Further Chiou in Col 118 Line 66 – Col 119 Line 12 reciting, “The virtual surgical plan can be developed with use of a computer or computer workstation as well as a local or remote computer or computer network. The computer or computer workstation can include one or more displays, keyboard, mouse, trackball, mousepad, joystick, human input devices, processor, graphics processors, memory chips, storage media, disks, and software, for example for 3D reconstruction, surface displays. . . The software can include one or more interfaces for CAD design, for displaying the patient's anatomy. . .and for displaying virtual implants, implant components, medical devices and/or medical device components.”)
Regarding Claim 20, Chiou in view of Numajiri discloses An apparatus for designing a patient-specific implant and guidance, the apparatus comprising: an input/output interface; a memory that stores an instruction; and a processor, wherein the processor is connected to the input/output interface and the memory to (Chiou in Col 118 Line 66 – Col 119 Line 12 reciting, “The virtual surgical plan can be developed with use of a computer or computer workstation as well as a local or remote computer or computer network. The computer or computer workstation can include one or more displays, keyboard, mouse, trackball, mousepad, joystick, human input devices, processor, graphics processors, memory chips, storage media, disks, and software, for example for 3D reconstruction, surface displays. . . The software can include one or more interfaces for CAD design, for displaying the patient's anatomy. . .and for displaying virtual implants, implant components, medical devices and/or medical device components.” Further in Col 120 Lines 23-27 reciting, “The position, orientation, alignment direction or place of the one or more of a surgical instrument, an implant component and an implant can optionally be aligned with hidden anatomy or internal structures 151, optionally using a virtual interface 150.”)
specifying a first skeleton image of a first part of a patient's skeleton, wherein the first part includes a region where a graft material is to be implanted; model a second skeleton image of a second part of the patient's skeleton, wherein the second part is different from the first part and includes the graft material; specify first spatial information on a first area to be cut in the first skeleton image; specify first spatial information on a second area to be implanted in the second skeleton image; and overlap the second skeleton image and the first skeleton image by matching the first spatial information with the second spatial information; design, based on the first skeleton image, a first guidance for cutting a skeleton corresponding to the first area to be cut from the patient's skeleton; design a plurality of fixing parts for fixing an actual skeleton to be cut corresponding to the first area to be cut in contact with the patient's skeleton; and design perforated holes for screw insertion on surfaces of some of the plurality of fixing parts, wherein the processor is further configured to, specifying of the first spatial information: generating one or more planes penetrating through the first skeleton image; selecting a specific closed area corresponding to the first area to be cut from among one or more closed areas defined in the first skeleton image by the one or more planes; and determining, as the first spatial information, a set of coordinates specified on at least two cut surfaces of the specific closed area. (Regarding the above limitations, these limitations are similar to those of Claim 1, and is therefore rejected under a similar rationale as Claim 1.)
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Chiou in view of Numajiri and in further view DUFOUR et al. (US 20200069372 A1) (Hereinafter referred to as DUFOUR).
Regarding Claim 6, Chiou in view of Numajiri discloses The method of claim 1, further comprising: applying a change in an angle to the second skeleton image overlapping the first skeleton image. (Chiou in Col 124 Lines 14-45 reciting, “If the surgeon elects to change or adjust any of a virtual surgical tool, virtual surgical instrument including a . . . virtual implant or virtual device, . . . predetermined angle or orientation or rotation marker, predetermined axis, . . . used in the one or more virtual surgical plans using, for example, a virtual interface displayed by the HMD display, . . . the virtual representation of the virtual data can move accordingly and the virtual data displayed in the HMD can be updated accordingly in the surgeon's display. The change in position and/or orientation of the virtual representation of the virtual data can also be seen in other HMDs”)
However, Chiou in view of Numajiri fails to disclose applying a change in an angle of at least one of a roll, a yaw, and a pitch
Dufour teaches applying a change in an angle of at least one of a roll, a yaw, and a pitch. ([0020] reciting “The step 10 of fitting the 3D bone model to the bone may include positioning and orienting the 3D bone model such that it becomes part of the coordinate system of the bone, i.e., points on the 3D bone model are given an x,y,z coordinate.” Further [0040] reciting, “For example, the robot arm 20 controls 6-DOF movements of the tool head 24, i.e., X, Y, Z in the coordinate system, and pitch, roll and yaw.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiou in view of Numajiri to include pitch, roll, and yaw when applying an angle change. The motivation would have been because pitch, roll and yaw is a common system of rotation.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chiou in view of Numajiri and in further view of YoungjunKim et al. (KR 10-1687634 B1) (Hereinafter referred to as YoungjunKim).
Regarding Claim 8, Chiou in view of Numajiri fails to disclose The method of claim 1, wherein the area to be cut and the area to be implanted are displayed with different opacities in a state where the first skeleton image and the second skeleton image are overlapped.
YoungjunKim teaches the area to be cut and the area to be implanted are displayed with different opacities in a state where the first skeleton image and the second skeleton image are overlapped. (See Figure 7 showing area to be cut and area to be implanted displayed at different opacities in a state where the images overlap)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiou in view of Numajiri to have the different opacities of the skeletons when overlapping. The motivation would have been to increase the clarity of visualization.
Claims 12, 13, 15, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Chiou in view of Numajiri in further view of Ma et al. (“3D printed personalized titanium plates improve clinical outcome in microwave ablation of bone tumors around the knee”) (Hereinafter referred to as Ma).
Regarding Claim 12, Chiou in view of Numajiri discloses The method of claim 11, wherein the designing of the first sub-fixing unit includes: designing a first sub-fixing part that is in contact with the cut surface of the area to be cut. (Numajiri showing a first guidance based on the first skeleton image with Figs. 5A, 5B, 6A and 6E in which the sub-fixing parts are shown to be in contact with the cut surface of the area to be cut.)
However, Chiou in view of Numajiri fails to disclose generating a first cover having a thickness equal to a first offset on a surface of the first skeleton image excluding the area to be cut; and designing a partial area of the first cover that is in contact with the cut surface of the area to be cut as a first sub-fixing part.
Ma teaches generating a first cover having a thickness equal to a first offset on a surface of the first skeleton image excluding the area to be cut; and designing a partial area of the first cover that is in contact with the cut surface of the area to be cut as a first sub-fixing part. (Ma in Page 2 reciting, “manufacture personalized (i.e. customized) plates to assist with bone reconstruction following microwave ablation of bone tumors. The general strategy of our study is schematically illustrated in Fig. 1. For the first time, we used the personalized titanium plates, which are made aligned well with the anatomical bone surface of the specific patient, to achieve excellent internal fixation after bone tumor resection.” Since the plates (cover) are manufactured, the thickness is adjustable so that it can be equal to some specified offset. Chiou in view of Numajiri teaches generating fixing parts that excludes the area to be cut. In combination with Ma, using the personalized titanium plates (cover), the first sub-fixing part can be designed based on a partial area of the titanium plates.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiou in view of Numajiri to include using titanium plates when designing sub-fixing parts. The motivation would have been to improve surgical outcomes. According to Ma, “personalized titanium plates can significantly improve the clinical outcomes in the surgical removal of bone tumor.” (Abstract).
Regarding Claim 13, Chiou in view of Numajiri and in further view of Ma discloses The method of claim 11, wherein the designing of the second sub-fixing unit includes: generating a second cover (personalized titanium plates, see Ma) having a thickness equal to a second offset (manufactured plates, See Ma) on a plane defining the area to be cut; (Numajiri showing planes defining the area for the to be cut in Fig. 2A. See Fig. 3D showing first and second subfixing ends attached to mandible (first skeleton image) around the area to be cut and orthogonal to the plane defining the area to be cut with the second sub fixing unit being orthogonal to the first.)
separating the second cover into two areas based on a plane defining the area to be cut; (Numajiri Fig. 3 is showing designing the mandibular cutting guide with planes. The figure description also describes using the planes in designing the cutting guide. Note that there exists are scenario in which the planes are used to separate the titanium plates (second cover) into two areas when creating the cutting guide for the mandible.)
selecting an area overlapping the first sub-fixing part from among the two separated areas; and selecting, as a second sub-fixing part, a partial area in contact with the cut surface of the area to be cut in the selected area. (Ma in combination with Chiou in view of Numajiri discloses using the personalized titanium plates (cover) and having the second sub-fixing part be designed based on a partial area of the titanium plates. See Numajiri Fig. 3. The motivation to combine would have been same as that of Claim 12 rejections.)
Regarding Claim 15, Chiou in view of Numajiri and in further view of Ma discloses The method of claim 14, wherein the designing of the handle part includes: generating a third cover (personalized titanium plates, see Ma) having a thickness equal to a third offset on the surface of the first skeleton image; (manufactured plates, See Ma) and
designing the handle part by connecting a specified point on at least two of the plurality of fixing parts and one or more specified points in the third cover. (Numajiri discloses connecting the ends of the sub-fixing parts with pillars in Fig. 3D. Ma in combination with Chiou in view of Numajiri would teach designing the handle part in respect with titanium plates based on the surface of the human skeleton and in that scenario, one or more specified points in the cover may be connect to the handle as the sub-fixing parts are design with the covers in mind. The motivation to combine would have been same as that of Claim 12 rejections.)
Regarding Claim 21, Chiou in view of Numajiri discloses The method of Claim 12, further comprising: designing additional perforated holes on a surface of the first sub-fixing unit. (Numajiri See Fig. 5A and 5D showing first and second sub-fixing ends attached with a handle between. Although Numajiri does not show the first sub-fixing unit having holes, it would be obvious to modify the design such that it does have them as taught by Chiou in Fig. 14C which shows holes for pins on a surgical guide.)
Regarding Claim 22 Chiou in view of Numajiri discloses The method of Claim 13, further comprising: designing additional perforated holes on a surface of the second sub-fixing unit. (Numajiri See Fig. 5A and 5D showing first and second sub-fixing ends attached with a handle between. Although Numajiri does not show the second sub-fixing unit having holes, it would be obvious to modify the design such that it does have them as taught by Chiou in Fig. 14C which shows holes for pins on a surgical guide.)
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Chiou in view of Numajiri and in further view of Kopačin (“Creating Personalized Cutting Guides for Free Fibula Flap Using Blender 2.83 Add-On FFF Gen PART 3”).
Regarding Claim 18, Chiou in view of Numajiri discloses The method of claim 17, wherein the designing of the second guidance includes: generating a hexahedron by using the plane defining the area to be cut and designing the second guidance by excluding an area of a second skeleton image partially overlapping the hexahedron in the hexahedron. (Numajiri See Fig. 4. Also Fig. 4 Description describes a “box-shaped solid” formed by connecting the cut planes and how the solid is subtracted (excluded) based on the structure of the skeleton.)
However Chiou in view of Numajiri fails to disclose generating a virtual first hexahedron surrounding the second skeleton image; reducing a volume of the first hexahedron and transforming the first hexahedron into a second hexahedron partially overlapping the second skeleton image; generating a third hexahedron by cutting the second hexahedron into a plane defining the area to be cut; and designing the second guidance by excluding an area of a second skeleton image partially overlapping the third hexahedron in the third hexahedron.
Kopačin teaches generating a virtual first hexahedron surrounding the cutting guide; (Starting at 16:14 of the video, one can see a virtual first hexahedron surrounding a cutting guide.) reducing a volume of the first hexahedron and transforming the first hexahedron into a second hexahedron partially overlapping the second skeleton image; (Then the hexahedron is shown to be able to increase and reduce in volume by the scaling from the user. By 16:30, the hexahedron is then shown to partially overlap the second skeleton image.)
Chiou in view of Numajiri and in further view of Kopačin would teach generating a virtual first hexahedron surrounding the second skeleton image; reducing a volume of the first hexahedron and transforming the first hexahedron into a second hexahedron partially overlapping the second skeleton image; generating a third hexahedron by cutting the second hexahedron into a plane defining the area to be cut; and designing the second guidance by excluding an area of a second skeleton image partially overlapping the third hexahedron in the third hexahedron. (Numajiri already shows the cut planes on the second skeleton image, see Fig. 4 and Kopačin is shown to be using the 3d modeling software, Blender, which is a software that is able to create a third hexahedron by having its original be divided by cut planes. Note that there exists a scenario in which a first virtual hexahedron is created in Blender surrounding the second skeleton image of Numajiri. After following the steps of Kopačin of transforming the first hexahedron into a second hexahedron, the cutting planes defined by Numajiri can be used to cut the second hexahedron transforming it into the third hexahedron.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiou in view of Numajiri to include using a modeling software like Blender when designing the second guidance. The motivation to combine would have been to increase the tools available when designing the surgical guidance. More tools can may improve the final resulting surgical guidance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANG G HUYNH whose telephone number is (571)272-5432. The examiner can normally be reached Mon-Thu 7:30am-4:30pm EST | Fri 7:30am-11:30am EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kee Tung can be reached at (571)272-7794. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.G.H./Examiner, Art Unit 2611
/KEE M TUNG/Supervisory Patent Examiner, Art Unit 2611