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 .
Acknowledgement of Amendment
The following office action is in response to the applicant’s amendment filed on 06/17/2026. Claims 1-18, and 20-21 are pending. Claims 1, 3, 8, 10 and 18 are amended. Claim 19 is cancelled. Claims 1-18 and 20-21 are rejected under 35 U.S.C. 103 for the reasons stated in the Response to Arguments and 35 U.S.C. 103 sections below.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/27/2025, 10/15/2025 and 06/17/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Applicant’s arguments, see Remarks page 10, filed 06/17/2026, with respect to the objections to the specification, claims and drawings have been fully considered and are persuasive. The objections to the specification, claims and drawings in the non-final rejection of 03/18/2026 has been withdrawn.
Applicant’s arguments, see Remarks page 11, filed 06/17/2026, with respect to the rejection of claims 1-7 under 35 U.S.C. 101 have been fully considered and are persuasive.
Regarding claim 1, the examiner acknowledges that the claims has been amended to explicitly recite outputting, by the MR device, the virtual object for display so that the virtual object appears to a user of the MR visualization device to pass through the target bone and indicates the planned surface of the target bone. The examiner agrees that this step is not abstract and addresses a technical problem (see [0025] of the Applicant’s specification).
The rejection of claims 1-7 under 35 U.S.C. 101 in the non-final rejection of 03/18/2026 has been withdrawn.
Applicant’s arguments, see Remarks page 11, filed 06/17/2026, with respect to the rejection of claims 1-18, and 20-21 under 35 U.S.C. 103 have been fully considered and are persuasive.
The Applicant respectfully transverses the rejections to the extent the rejections may be considered applicable to the claims as amended. The applied references alone or in any combination, fail to disclose or suggest the features defined by Applicant’s claims, and there would have been no apparent reason that would have caused one of ordinary skill in the art to modify the applied references to arrive at the claimed features.
In particular, independent claim 1 requires: “wherein the targe bone is a bone fragment that has been removed from another bone or a patient or a donor”; “wherein the platform comprises a reference marker”; and “while the target bone is positioned on the bone support member of the platform”. The examiner acknowledges that support for these claim amendments can be found at least in paragraph [0021] of the specification as filed.
The applicant notes that Poltaretskyi fails to teach or suggest a configuration where “the target bone is a bone fragment that has been removed from another bone or a patient or a donor”. Because Poltaretskyi does not disclose each and every element arranged as in the claim, Poltaretskyi does not anticipate the claimed subject matter. The Applicant therefore respectfully requests the withdrawal of the rejection.
The examiner respectfully agrees that Poltaretskyi does not teach “wherein the target bone is a bone fragment that has been removed from another bone or a patient or a donor”; “wherein the platform comprises a reference marker”; and “while the target bone is positioned on the bone support member of the platform”.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tidwell US 5,540,692 A “Tidwell” as discussed in the 35 U.S.C. 103 section below.
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.
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.
Claim(s) 1-16, 18, and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poltaretskyi et al. US 2019/0380792 A1 “Poltaretskyi” and further in view of Tidwell US 5,540,692 A “Tidwell”.
Regarding claims 1, 8 and 18, Poltaretskyi teaches “A method comprising:” (Claim 1) (“Accordingly, this disclosure describes systems and methods for using a mixed reality (MR) visualization system to assist with creation, implementation, verification, and/or modification of a surgical plan before and during a surgical procedure” [0163]; “In this way, in one example, a mixed reality surgical planning method includes generating a virtual surgical plan to repair an anatomy of interest of a particular patient” [0344]. Additionally, claims 1-17 of Poltaretskyi discloses a method with multiple steps. Thus, Poltaretskyi discloses a method.);
“A system comprising: a mixed reality (MR) visualization device; and processing circuitry configured to:” (Claim 8) (“FIG. 2 is a block diagram of an orthopedic surgical system 200 that includes one or more mixed reality (MR) systems, according to an example of this disclosure” [0177]; “In some examples of this disclosure, MR system 212 includes one or more processing device(s) (P) 210 to provide functionalities that will be described in further detail below. Processing device(s) 210 may also be referred to as processor(s)” [0179]; “Processing device(s) 210 may be configured to control visualization device 213 to present a user interface. Furthermore, processing device(s) 210 may be configured to control visualization device 213 to present virtual images, such as 3D virtual models, 2D images, and so on” [0181]; “In some examples, visualization device 213 is wearable by a user. In some examples, visualization device 213 is held by a user, or rests on a surface in a place accessible to the user. MR system 212 may be configured to present a user interface via visualization device 213” [0187]. Additionally, FIG. 5 shows an example of the visualization device 213.
Therefore, FIG. 2 shows a system (i.e. 200) comprising: a mixed reality (MR) visualization device (i.e. MR system 212 with visualization device 213, see FIG. 5) and processing circuitry (i.e. processing device(s) (P) 210) configured to carry out specific functions.);
“One or more non-transitory computer-readable storage medium media having instructions stored thereon that, when executed by one or more processors of a computing system, cause the computing system to:” (Claim 18) (“In one or more examples, the functions described may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on or transmitted over as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include computer-readable storage media, which corresponds to a tangible medium such as data storage media, or communication media including any medium that facilitates transfer of a computer program from one place to another, e.g., according to a communication protocol. In this manner, computer-readable media generally may correspond to (1) tangible computer-readable storage media which is non-transitory or (2) a communication medium such as a signal or carrier wave. […]” [1155]; “By way of example, and not limitation, such computer-readable storage media can comprise RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage, or other magnetic storage devices, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer” [1156]. Therefore, Poltaretskyi discloses one or more non-transitory computer-readable storage medium media having instructions stored thereon that, when executed by one or more processors of a computing system, cause the computing system to perform specific steps.);
“receiving, by a computing system, tracking input of a scene in which a target bone is positioned on a bone support member of a platform, wherein the platform comprises a reference marker” (Claim 1); “receive tracking input of a scene in which a target bone is positioned on a bone support member of a platform, wherein the platform comprises a reference marker” (Claims 8 and 18) (“MR system 212 may utilize data from one or more sensors (e.g., one or more of sensors 614 of visualization device 213 of FIG. 6) to identify the location of the physical markers (2020). For instance, MR system 212 may use data generated by any combination of depth sensors 532 and/or optical sensors 530 to identify a specific position (e.g., coordinates) of each of the physical markers. As one specific example, MR system 212 may utilize optical data generated by optical sensors 530 to identify a centroid of optical marker 3010A of FIG. 30A. […] For instance, MR system 212 may determine a distance between a centroid of fiducial marker 3010A and tip 3010B of optical marker 3010 of FIG. 30A. Based on the determined distance (i.e., between the centroid and the attachment point) and the determined position/orientation of the centroid, MR system 212 may determine a position/orientation of the attachment point” [0301]; “In general, the physical markers may be placed anywhere. For instance the physical markers can be attached to the patient (e.g., non-sterile field), surgically exposed anatomy (sterile field), instruments, anywhere in the surgical field of vier, or any other suitable location” [0288]; “The physical markers can be any type of marker that enables identification of a particular location relative to the real observed object (e.g., bone structure 2200). Examples of physical markers include, but are not necessarily limited to, passive physical markers and active physical markers” [0289]; “Active physical markers may perform one or more actions that aid in their identification by MR system 212. For instance, active physical markers may output signals (e.g., electromagnetic signals) that aid in their identification by MR system 212” [0292]; “In some examples, in the course of an orthopedic surgical procedure, a surgeon may perform one of more work operations, which also may be referred to as surgical steps, with the assistance of a mechanical guide. For instance, as shown in FIG. 33, a surgeon may attach mechanical guide 3300 on humerus 3200 prior to performing a resection of humeral head 3204 (e.g., as part of performing the humerus cut process of step 1902 of FIG. 19). The surgeon may adjust one or more components of mechanical guide 3300 such that top surface 3302 of mechanical guide 3300 is co-planar with anatomic neck 3202 of humerus 3200 (for purposes of illustration, anatomic neck 3202 is illustrated as a broken line). After attaching mechanical guide 3300 to humeral head 3204 and adjusting the mechanical guide, the surgeon may perform the resection of humeral head 3204 by guiding a cutting tool (e.g., a blade of an oscillating saw) along top surface 3302.” [0356].
While FIG. 30A shows optical sensors 530/physical markers 2020 being present on a scapula, it would be obvious to one of ordinary skill in the art to include these optical sensors 530/physical markers 2020 on any target anatomy of interest, such as, for example, the humerus (i.e. see FIGS. 32-49). Furthermore, the mechanical guide 3300 represents a bone support member with a platform. Additionally, since physical markers may be placed anywhere including instrument or anywhere in the surgical field of view (see [0288]), the platform comprises a reference marker. Therefore, since the MR system 212 may utilize data from one or more sensors to identify the position of an optical marker (i.e. 3010) on the scapula (i.e. bone) of a patient method involves receiving, by a computing system, tracking input (i.e. from optical sensors) of a scene (i.e. scapula (2200) scene shown in FIG. 30A, for example; humerus (3200) scene, see FIG. 32A/42A) in which a target bone is positioned on a bone support member (i.e. mechanical guide 3300) of a platform, wherein the platform comprises a reference marker (i.e. physical sensor, see [0288]).);
“generating, by the computing system, registration data that registers the reference marker with a coordinate system” (Claim 1); “generate registration data that registers the reference marker with a coordinate system” (Claims 8 and 18) (“MR system 212 may register the virtual model with the observed anatomy based on the identified positions (2022) of the physical markers. For instance, where the physical markers are placed on the observed bone structure 2200 at locations that correspond to specific location(s) on the virtual model that corresponds to the observed bone structure 2200, MR system 212 may generate a transformation matrix between the virtual model and the observed bone structure 212” [0302]; “As discussed above, a virtual model of humerus 3200 may be registered with humerus 3200 such that coordinates on the virtual model approximately correspond to coordinates on humerus 3200. As such, by displaying virtual cutting plane 4200 at the determined location on the virtual model, MR system 212 may display virtual cutting plane 4200 at the planned position on humerus 3200.” [0392]. Therefore the method carried out by the system involves generating, by the computing system, registration data that registers the reference marker (i.e. humerus 3200, for example) with a coordinate system (i.e. virtual model).);
“obtaining, by the computing system, data defining a planned surface of the target bone” (Claim 1); “obtain data defining a planned surface of the target bone” (Claims 8 and 18) (“FIGS. 42A-42C are conceptual diagrams illustrating an MR system providing virtual guidance for resection of a humeral head, in accordance with one or more techniques of this disclosure. As shown in FIGS. 42A and 42B, MR system 212 may display virtual cutting plane 4200 at a planned position on humerus 3200. To display virtual cutting plane 4200, MR system 212 may determine a location on a virtual model of humerus 3200 at which humeral head 3204 is to be resected” [0391]. In this case, the virtual cutting plane 4200 represents a planned surface of the target bone (i.e. humerus 3200). Therefore, the method carried out by the system involves obtaining, by the computing system, data defining a planned surface of the target bone (i.e. virtual cutting plane 4200).);
“determining, by the computing system, based on the registration data, a position in the coordinate system for a virtual object representing the planned surface of the target bone” (Claim 1); “determine, based on the registration data, a position in the coordinate system for a virtual object representing the planned surface of the target bone” (Claims 8 and 18) (“MR system 212 may obtain the location from a virtual surgical plan (e.g., the virtual surgical plan described above). As such, MR system 212 may display a virtual cutting surface (e.g., cutting plane) having parameters (e.g., position, size, and/or orientation relative to the virtual model of the humerus) obtained from the virtual surgical plan that guides resection of a portion of a head of the humerus” [0391]. Therefore, since the MR system 212 may obtain the location from a virtual surgical plan (see [0302]) and use it to display a virtual cutting plane (i.e. 4200, for example), the method carried out by the system involves determining, by the computing system, based on the registration data (see [0302]), a position in the coordinate system for a virtual object representing the planned surface of the target bone (i.e. humerus, for example) ; and
“while the target bone is positioned on the bone support member of the platform and while a position in the coordinate system of the target bone and the position in the coordinate system for the virtual object are within a field of view of a mixed reality (MR) visualization device, outputting/cause, [by] the MR visualization device the virtual object for display so that the virtual object appears to a user of the MR visualization device to pass through the target bone and so that the virtual object indicates the planned surface of the target bone” (Claims 1, 8 and 18) (See FIGS. 42A-42C and “As such, MR system 212 may display a virtual cutting surface (e.g., cutting plane) having parameters (e.g., position, size, and/or orientation relative to the virtual model of the humerus) obtained from the virtual surgical plan that guides resection of a portion of a head of the humerus” [0391] and “The presentation virtual guidance such as of a virtual cutting plane may enable a surgeon to accurately resect the humeral head without the need for a mechanical guide, e.g., by guiding a saw along the virtual cutting plane displayed via the visualization system while the surgeon views the actual humeral head. In this way, a visualization system, such as MR system 212 with visualization device 213, may enable surgeons to perform accurate work (e.g., with the accuracy of mechanical guides but without the disadvantages of using mechanical guides)” [0359]. Therefore, while a position in the coordinate system of the target bone and the position in the coordinate system for the virtual object (i.e. virtual model) is within a field of view of a mixed reality (MR) visualization device, outputting, the MR visualization device, the virtual object (i.e. virtual cutting plane 4200) for display so that the virtual object appears to a user of the MR visualization device to pass through the target bone (i.e. humerus 3200, for example) and so that the virtual object indicates the planned surface (i.e. cutting plane) of the target bone.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method, system and one or more non-transitory computer-readable storage media of Poltaretskyi such that it involves receiving tracking input of a scene in which a target bone (i.e. humerus, for example) is positioned on a bone support member (i.e. mechanical guide 3300) of a platform, wherein the platform comprises a reference marker (i.e. physical marker, see [0288]) in order to allow a surgeon to effectively perform an orthopedic surgical procedure in a specific, known location. Securing a bone within a mechanical guide 3300 (i.e. bone support member of a platform) and identifying the location of a reference marker on the platform is one of a finite number of techniques which can be used to perform an accurate resection procedure and design of an implant with a reasonable expectation of success. Thus, modifying the method, system and one or more non-transitory computer-readable storage media of Poltaretskyi such that it involves receiving tracking input of a scene in which a target bone (i.e. humerus, for example) is positioned on a bone support member (i.e. mechanical guide 3300) of a platform, wherein the platform comprises a reference marker (i.e. physical marker, see [0288]) would yield the predictable result of allowing a surgeon to effectively perform an orthopedic surgical procedure in a specific, known location.
Poltaretskyi does not teach “wherein the target bone is a bone fragment that has been removed from another bone of a patient or a donor” (Claims 1, 8, and 18).
Tidwell is within the same field of endeavor as the claimed invention because it involves a replicator for precisely resecting bone into a desired shape, the replicator including a which includes a bone holder (see [Abstract]).
Tidwell teaches “wherein the target bone is a bone fragment that has been removed from another bone of a patient or a donor” (Claims 1, 8, and 18) (“Bone support member 37 includes bone plate 81, into which a plurality of holes are formed for mounting screw clamps 83. Bone plate 81 is a circular rotatable plate. Bone plate 81 is rotatable about bone axis 85, which extends parallel to pattern axis 47. Screw clamps 83 are spaced 120 degrees apart from each other for tightening against a section of a bone 39. Bone 39 will typically be a section of a donor bone for implanting in a human body. For example, bone 39 may be a femur or a knee joint. Bone plate 81 can be rotated relative to frame 13 for preselected angular distances about axis 85 of bone support member 37” [Column 3, Lines 36-46].
Therefore, the target bone (i.e. bone 39) is a bone fragment that has been removed from another bone or a patient or a donor (i.e. a donor bone).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method, system and one or more non-transitory computer-readable storage media of Poltaretskyi such that it involves receiving tracking input of a scene in which a target bone (i.e. humerus, for example) is positioned on a bone support member (i.e. bone support member 37) of a platform, wherein the target bone is a bone fragment that has been removed from another bone of a patient or a donor as disclosed in Tidwell in order to effectively design an implant such that is can be implanted within a patient (see Tidwell: [Column 6, Lines 5-6]: “Once completed, the surgeon will remove donor bone 39 and implant it in the patient”). Placing a donor bone on a bone support member and modifying it based on a repositioning pattern is one of a finite number of techniques which can be used to generate an implant specific to a patient with a reasonable expectation of success. Thus, modifying the method, system and one or more non-transitory computer-readable storage media of Poltaretskyi such that it involves receiving tracking input of a scene in which a target bone (i.e. humerus, for example) is positioned on a bone support member (i.e. bone support member 37) of a platform, wherein the target bone is a bone fragment that has been removed from another bone of a patient or a donor as disclosed in Tidwell would yield the predictable result of effectively designing an implant such that is can be implanted within a patient (see Tidwell: [Column 6, Lines 5-6]: “Once completed, the surgeon will remove donor bone 39 and implant it in the patient”).
Regarding claims 2, 9 and 21, Poltaretskyi in view of Tidwell discloses all features of the claimed invention as discussed with respect to claims 1, 8 and 18 above, and Poltaretskyi further teaches “wherein the virtual object indicates one or more cutting planes” (Claims 2, 9 and 21) (See [0391] as discussed with respect to claims 1, 8 and 18 above. Therefore, since the MR system 212 may display virtual cutting plane 4200 at a planned position on humerus 3200 (see FIG. 42B), the method carried out by the system involves displaying the virtual object which indicated one or more cutting planes.).
Regarding claims 3 and 10, Poltaretskyi in view of Tidwell discloses all features of the claimed invention as discussed with respect to claims 1 and 8 above, and Poltaretskyi further teaches “wherein the planned surface of the target bone is shaped to engage a second bone of the patient” (Claims 3 and 10) (“FIG. 41 is a conceptual diagram illustrating an MR system providing virtual guidance for cutting of a graft in a humeral head, in accordance with one or more techniques of this disclosure. As shown in FIG. 41, the reaming and drilling work steps discussed above may result in graft 4102 having a toroid shape with the bottom surface still attached to humerus 3200” [0387]; “As such, MR system 212 may display a virtual cutting plane having parameters (e.g., position, size, and/or orientation relative to the virtual model of the humeral head) obtained from a virtual surgical plan that guides cutting of a graft from a humeral head” [0388]; “The surgeon may utilize the graft for any purpose. For instance, the surgeon may utilize the graft to fill empty space between a prosthesis an[d] a glenoid of the patient and/or provide/increase an offset when attaching a prosthesis to a glenoid of the patient” [0389]. Therefore, since the graft 4102 has a toroid shape which is utilized to fill empty space between a prosthesis and a glenoid, the planned surface of the target bone is shaped to engage a second bone of a patient (i.e. glenoid, see [0389].).
Regarding claims 4 and 11, Poltaretskyi in view of Tidwell discloses all features of the claimed invention as discussed with respect to claims 3 and 10 above, and Poltaretskyi further teaches “wherein: the planned surface of the target bone is a first surface of the target bone, and a second surface of the target bone opposite the first surface of the target bone is shaped to engage an orthopedic prosthesis” (Claims 4 and 11) (See [0387], [0388] and [0389] as discussed with respect to claims 3 and 10 above. Therefore, since the MR system 212 displays a virtual cutting plane 4100 corresponding to graft 4102, and the graft is used to fill empty space between a prosthesis and a glenoid, the planned surface of the target bone (i.e. humerus) is a first surface of the target bone (i.e. graft 4102), and a second surface of the target bone opposite the first surface of the target bone (i.e. humeral head 3204 (see FIG. 41) which connects to the prosthesis/glenoid, see [0389]) is shaped to engage an orthopedic prosthesis.).
Regarding claims 5 and 12, Poltaretskyi in view of Tidwell discloses all features of the claimed invention as discussed with respect to claims 1 and 8 above, and Poltaretskyi further teaches “wherein: the target bone is cylindrical, and the bone support member is cylindrical and has a raised rim that has an inner diameter that substantially matches an outer diameter of the target bone” (Claims 5 and 12) (See FIG. 33 and [0356] as discussed with respect to claims 1 and 8 above. As shown in FIG. 33, the target bone (i.e. humerus 3200) is cylindrical and the bone support member (i.e. mechanical guide 3300 is cylindrical and has a raised rim (i.e. circular portion) that has an inner diameter that substantially matches (i.e. is co-planar with) an outer diameter (i.e. anatomic neck 3202) of the target bone.).
Regarding claims 6, 14 and 20, Poltaretskyi in view of Tidwell discloses all features of the claimed invention as discussed with respect to claims 1, 8 and 18 above, and Poltaretskyi further teaches “wherein: the platform further comprises: a base plate; and a marker stem that supports the reference marker at a predefined height above the base plate, wherein the bone support member and the marker stem are connected to the base plate” (Claims 6 and 20); “wherein the system comprises the platform and the platform further comprises: a base plate; and a marker stem that supports the reference marker at a predefined height above the base plate, wherein the bone support member and the marker stem are connected to the base plate” (Claim 14) (See annotated FIG. 33 below. Therefore, the platform (i.e. mechanical guide 3300) further comprises: a base plate and a marker stem that supports the reference marker at a predefined height (i.e. distance) above the base plate, wherein the bone support member and the marker stem are connected to the base plate.
PNG
media_image1.png
533
362
media_image1.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mechanical guide 3300 of Poltaretskyi such that a reference marker is included in the stem portion denoted in the annotated figure above in order to allow for accurate tracking of the mechanical guide when it is attached to the bone (i.e. humerus 3200) of the patient. Attaching a reference marker to a device is one of a finite number of techniques which can be used to track that device with a reasonable expectation of success. Thus, modifying the mechanical guide 3300 of Poltaretskyi such that a reference marker is included in the stem portion denoted in the annotated figure above would yield the predictable result of allowing for accurate tracking of the mechanical guide when it is attached to the bone (i.e. humerus 3200) of the patient.
Regarding claims 7 and 16, Poltaretskyi in view of Tidwell discloses all features of the claimed invention as discussed with respect to claims 1 and 8 above, and Poltaretskyi further teaches “further comprising providing, by the computing system, feedback to the user of the MR visualization device based on alignment of a surgical instrument with the planned surface of the target bone” (Claim 7); “wherein the processing circuitry is further configured to provide feedback to the user of the MR visualization device based on alignment of a surgical instrument with the planned surface of the target bone” (Claim 16) (“The surgeon may resect humeral head 3204 using the displayed virtual guidance. For instance, the surgeon may utilize oscillating saw 4104 to resect humeral head 3204 by cutting along virtual cutting plane 4200. In some examples, MR system 212 may display targeting guidance to indicate whether the tool (e.g., oscillating saw 4104) is on the prescribed plane” [0393]. Therefore, since the MR system 212 may display targeting guidance to indicate whether the tool (i.e. oscillating saw 4104) is on the virtual cutting plane 4200 (see FIGS. 42A-42B), the method carried out by the system further comprises providing, by the computing system, feedback (i.e. targeting guidance) to the user of the MR visualization device (i.e. MR system 212 with the visualization device 213, see FIGS. 2 and 5) based on alignment of a surgical instrument (i.e. oscillating saw 4104) with the planned surface (i.e. virtual cutting plane 4200) of the target bone.).
Regarding claim 13, Poltaretskyi in view of Tidwell discloses all features of the claimed invention as discussed with respect to claim 12 above, and Poltaretskyi further teaches “wherein the bone support member has a raised central protrusion having a diameter that approximately matches a diameter of a central circular incision in the target bone” (“In order to prepare the humerus for implantation of the prosthesis, the surgeon may resect, cut, or otherwise remove the humeral head. Several MR assisted techniques for humeral head resection are contemplated […] In a second example technique, MR system 212 may display a virtual axis that guides the surgeon in installing a physical guide, i.e., mechanical guide, on the humerus, which then guides the surgeon in resecting the humeral head. Further details of the second example technique are discussed below with reference to FIG. 43” [0390]; “FIG. 43 is a conceptual diagram illustrating a physical guide for humeral head resection that is positioned using virtual guidance, in accordance with one or more techniques of this disclosure. As discussed above, in the second example technique, MR system 212 may display a virtual axis that guides the surgeon in installing a physical guide, which guides the surgeon in resecting the humeral head. […] The surgeon may use the virtual axis to guide installation of physical guide 3500 (e.g., a guide pin)” [0394]; “The surgeon may use guide 3500 to assist in the installation of resection guide 4300 (e.g., the guide pin may be configured to guide attachment of a resection guide to the humerus)” [0395]; “Guide receiver 4310 may be sized to accept guide 3500 such that resection guide 4300 may be passed over guide 3500. Plates 4302 define slot 4304, which may be sized to receive and guide a physically guide a tool (e.g., an oscillating saw) between plates 4302 and across cutting plane 4312” [0396].
As shown in FIG. 43, the resection guide 4300 includes the guide receiver 4310 in the center of the upper plate 4308, the resection guide 4300 being positioned over the humerus 3200 via the guide 3500. Thus, the resection guide 4300 represents a bone support member. The guide 3500, in this case, is inserted into the humerus 3200 with a circular incision (i.e. indicated by the cylindrical shape of the guide 3500). Therefore, the bone support member (i.e. resection guide 4300) has a raised central protrusion (i.e. guide receiver 4310) having a diameter that approximately matches (i.e. since the receiver 4310 accepts the diameter of the guide 3500) a diameter of a central circular incision (i.e. caused by the guide 3500) in the target bone (i.e. humerus 3200).).
Regarding claims 15, Poltaretskyi in view of Tidwell discloses all features of the claimed invention as discussed with respect to claim 14 above, and Poltaretskyi further teaches “wherein the reference marker is a cube having different predefined optical patterns on each face other than a face to which the marker stem is connected” (“As shown in the examples of FIG. 30A and FIG. 30B, a fixed optical marker 3010 may be used in a shoulder arthroplasty procedure to define the location of the acromion of the scapula on the real observed bone structure 2200. In the example of FIG. 30A, fixed optical marker 3010 may include a planar fiducial marker 3010A on a single face of the optical marker. In the example of FIG. 30B, fixed optical marker 3010 may include planar fiducial markers 3010A on multiple faces of the optical marker. Where a physical marker includes fiducial markers of multiple faces, the fiducial markers may be the same on every face or different faces may include different fiducial markers” [0286]. As shown in FIG. 30B, the planar fiducial markers 3010A (i.e. optical markers) are of different patterns on each of the visible faces of the cube. Although this fixed optical marker 3010 is described with respect to the scapula, it would be obvious to one of ordinary skill in the art to utilize this fixed optical marker 3010 (see FIG. 30B) to observe different bones, such as the humerus 3200 shown in FIG. 33. Therefore, the reference marker (i.e. 3010) is a cube having different predefined optical patterns on each face other than a face to which the marker stem (i.e. 3010B in FIG. 30B) is connected.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mechanical guide 3300 of Poltaretskyi such that it includes the reference marker 3010 of FIG. 30B on the stem shown in annotated FIG. 33 (shown above with respect to claims 4, 6 and 20) in order to allow for accurate tracking of the mechanical guide when it is attached to the bone (i.e. humerus 3200) of the patient. Attaching a reference marker to a device is one of a finite number of techniques which can be used to track that device with a reasonable expectation of success. Thus, modifying the mechanical guide 3300 of Poltaretskyi such that it includes the reference marker 3010 of FIG. 30B on the stem shown in annotated FIG. 33 (shown above with respect to claims 4, 6 and 20) would yield the predictable result of allowing for accurate tracking of the mechanical guide when it is attached to the bone (i.e. humerus 3200) of the patient.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poltaretskyi et al. US 2019/0380792 A1 “Poltaretskyi” and Tidwell US 5,540,692 A “Tidwell” as applied to claim 8 above, and further in view of Mitra et al. US 2021/0322148 A1 “Mitra”.
Regarding claims 17, Poltaretskyi in view of Tidwell discloses all features of the claimed invention as discussed with respect to claim 8 above. While Poltaretskyi discloses “As an example, the information generated by MR system 212, including registration and tracking, can be used to control robotic arms that may be present in an operating environment” [0911], Poltaretskyi does not explicitly teach the system “further comprising a robot having a robotic arm configured to stabilize a surgical instrument used to shape the target bone”.
Mitra is within the same field of endeavor as the claimed invention because it involves a computer-assisted surgical system (CASS) 200 which includes an augmented reality (AR) Head Mounted Device (HMD) 255 on the head of a surgeon 211 and a robotic arm 205A useful for stabilizing the surgeon when performing a procedure (see FIG. 2, [0046]; [0058]; and [0086]).
Mitra teaches “further comprising a robot having a robotic arm configured to stabilize a surgical instrument used to shape the target bone” (“The robotic arm 205A may also be used for resurfacing applications. For example, the robotic arm 205A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 205A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan” [0086]; “In some embodiments, the end effectors 205B of the robotic arm 205A are operatively coupled with cutting guide 205D. In response to an anatomical model of the surgical scene, the robotic arm 205A can move the end effectors 205B and the cutting guide 205D into position to match the location of the femoral or tibial cut to be performed in accordance with the surgical plan” [0096]. As shown in FIG. 2, the surgeon 211 is holding end effector 205B which represents a handpiece. Thus, since the robotic arm 205A may be used for resurfacing applications (i.e. resurfacing/reshaping bone, for example) and may stabilize the surgeon while using traditional instrumentation (i.e. end effector 205B) and imposes restrictions on the handpiece to prevent the surgeon from removing unintended bone, the system further comprises a robot having a robotic arm configured to stabilize a surgical instrument (i.e. end effector 205B, for example) used to shape the target bone (i.e. femur/tibia, for example, see [0096]).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Poltaretskyi in view of Tidwell such that it further comprises a robot having a robotic arm configured to stabilize a surgical instrument used to shape the target bone as disclosed in Mitra in order to prevent the surgeon from removing unintended bone when performing carrying out a surgical plan (see Mitra: [0086]). A robot/robotic arm is one of a finite number of devices which can be utilized within a surgical space in order to stabilize a surgeon’s handpiece when performing a surgical procedure in order to ensure that the handpiece only moves in a limited manner and thus avoids unnecessary damage to a patient’s tissues with a reasonable expectation of success. Thus, modifying the system of Poltaretskyi such that it further comprises a robot having a robotic arm configured to stabilize a surgical instrument used to shape the target bone as disclosed in Mitra would yield the predictable result of preventing the surgeon from removing unintended bone when performing carrying out a surgical plan (see Mitra: [0086]).
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 KAITLYN E SEBASTIAN whose telephone number is (571)272-6190. The examiner can normally be reached Mon.- Fri. 7:30-4:30 (Alternate Fridays Off).
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, Anne M Kozak can be reached at (571) 270-0552. 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.
/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
Prosecution Insights