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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/27/2025 and 10/15/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
FIG. 1: Although the specification states “In the example of FIG. 1, system 100 includes a computing system 102, which includes a MR visualization device 104” [0026], this figure does not include the label 104.
FIG. 2A: Although the specification states “FIG. 2A shows a pin guidance jig200 attached to a humerus 202. Pin guide jig 200 includes a punch element 204 that penetrates humerus 202 along a lengthwise axis of humerus 202. Pin guidance jig 200 also includes a cannulated element 206. Cannulated element 206 defines a channel that guides a surgical pint 208 into a head of humerus 202” [0035], this figure does not include the label 206. Rather this label includes two labels 208. The examiner believes that the label 208 that is farther from the humerus 202 is intended to be the label 206. If this assumption is correct the examiner would recommend updating the drawing accordingly.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0037]: As written it reads “A circular incision 220 in humerus 202 made by outer cutting element 212 and a circular incision 222 in humerus 202 made by central cutting element 214 are visible in part 3 of FIG. 2”. However, FIG. 2 does not include part 3. The examiner believes that part 3 corresponds to FIG. 2C. If this assumption is correct, the examiner would recommend updating the specification accordingly.
[0052]: As written it reads “Registration system 716 may perform one or various implementations of SLAM algorithms, such as a SLAM algorithm having a particular filter implementation, an extended Kalman filter implementation, a covariance intersection implementation, a GraphSLAM implementation, an ORB SLAM implementation, or another implementation”. However, this is the first indication of the term “ORB” therefore, the term should be spelled out to provide clarity.
[0110]: As written it reads “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”. However, this is the first indication of the terms “ROM”, “EEPROM”, “CD-ROM” within the specification. Therefore, the terms should be spelled out to provide clarity.
Appropriate correction is required.
Claim Objections
Claim 14 is objected to because of the following informalities:
Regarding claim 14, as written it reads “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 the base plate”. However, to be grammatically correct “to” should be added between “connected” and “the base plate” (underlined above).
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea, specifically a mental process, without significantly more.
Regarding claim 1, the examiner notes that the claim is directed to a method. Therefore, the claim falls within one of the statutory categories of invention.
With reference to Step 2A, Prong One, the claim recites “obtaining, by the computing system, data defining a planned surface of the target bone; 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”.
The limitations, under broadest reasonable interpretation, cover performance of the limitation in the mind and/or read on viewing an image and deciding where to place a planned surface (i.e. one or more cutting planes) on said image. In this case, the obtaining and determining steps represent actions which can be practically performed in the human mind by a user viewing an image and providing an input to a system in order to specify the positioning of a planned surface (i.e. one or more cutting planes) within the image. If a claim limitation under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components (i.e. a processor), then it falls within the “mental processes” grouping of abstract ideas.
Following step 2A, Prong Two of the two-prong analysis, the claim recites the following additional elements: “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; generating, by the computing system, registration data that registers the reference marker with a coordinate system; […] while the target bone is positioned on the bone support member of the platform and whole a position in the coordinate system of the target bone and the position in the coordinate system for causing the virtual object is within a field of view of a mixed reality (MR) visualization device, causing, by the computing system, the MR visualization device to output 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 indicated the planned surface of the target bone”. These additional elements do not integrate the judicial exception into a practical application because the claim as written does not include elements to 1) improve the functioning of a computer (See MPEP 2106.05(a)); 2) effect a particular treatment or prophylaxis (See MPEP 2106.04(d)(2)); 3) use a particular machine (See MPEP 2106.05(b)); 4) use the judicial exceptions in a meaningful way beyond generally linking the use to a particular technological environment (See MPEP 2106.05(h)). Furthermore, these receiving, generating and causing steps do not integrate the judicial exception into a practical application because they add insignificant extra-solution activity (i.e. data-gathering and post-solution activity) to the judicial exception using a well-known device (i.e. computing system/processor, mixed reality MR visualization device, see 210 in FIG. 2 and 213 in FIG. 5 in Poltaretskyi et al. US 2019/0380792 A1 “Poltaretskyi”) (See MPEP 2106.05(g)).
Following step 2B, the additional element(s) (i.e. “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; generating, by the computing system, registration data that registers the reference marker with a coordinate system; […] while the target bone is positioned on the bone support member of the platform and whole a position in the coordinate system of the target bone and the position in the coordinate system for causing the virtual object is within a field of view of a mixed reality (MR) visualization device, causing, by the computing system, the MR visualization device to output 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 indicated the planned surface of the target bone”) do not amount to significantly more than the judicial exception the these limitations represent data gathering steps which utilize conventional tools (i.e. computing system/processors, mixed reality MR visualization device)) to perform well understood, routine and conventional activity (i.e. obtaining tracking input of a surgical scene, performing registration, displaying a virtual object on an MR visualization device, see 210 in FIG. 2, [0302], [0392] and 213 in FIG. 5 in Poltaretskyi et al. US 2019/0380792 A1 “Poltaretskyi” ) in the field, to perform the abstract idea.
Regarding claims 2-7, the claims add additional limitations that append the judgement of claim 1 and/or do not include additional elements that are sufficient to amount to significantly more than the judicial exception, nor a practical application of the judicial exception because they disclose:
provide additional information about the virtual object/planned surface/target bone/bone support member/platform (i.e. “wherein the virtual object indicated one or more cutting planes”, claim 2, “wherein the planned surface of the targe bone is shaped to engage a second bone of a patient”, claim 3; “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”, claim 4; “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”, claim 5; “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”, claim 6);
and/or constitute insignificant extra-solution activity (i.e. “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” in claim 7).
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”.
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 is within a field of view of a mixed reality (MR) visualization device, cause(ing), [by the computing system], the MR visualization device to output 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” (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, cause(ing), [by the computing system], the MR visualization device to output 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 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 prior to performing a resection process is one of a finite number of techniques which can be used to perform an accurate resection procedure 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.
Regarding claims 2, 9 and 21, Poltaretskyi 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 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 a 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 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 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 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, 14 and 20) (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.
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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 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 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 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” as applied to claim 8 above, and further in view of Mitra et al. US 2021/0322148 A1 “Mitra”.
Regarding claims 17, Poltaretskyi 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 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jaramaz et al. US 2015/0245878 A1 “Jaramaz” “FIG. 1C illustrates an example of positioning the cut guide 100 onto the target bone 300 such as via coupling between the protruding portion 131A-B and the coupling receptacles 331A-B. The guide members 120A-D can guide a cutting tool (not shown) to cut the target bone 300 along the cutting trajectories 150A-D as defined by the orientations of the guide members 120A-D” [0029]; “.
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