DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 3/24/2026 has been entered. Claims 1-20 remain pending the application.
Response to Arguments
Applicant's arguments filed on 3/24/2026 have been fully considered but they are moot.
Applicant argues on pages 7-10 that the previous rejection fails to address the newly added limitations in the claims related to calculating a required minimum distance. This argument is moot in view of the new grounds of rejection necessitated by amendment which relies on newly cited section of McKinnon and Tang to disclose these limitations in the claims. Accordingly, this argument is moot.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 9-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon and Tang et al. (Tang H-C et al., Distraction Gap Needed for Safe Central Compartment Access in Hip Arthroscopy. The American Journal of Sports Medicine. 2023;51(5):1211-1216. doi:10.1177/03635465231160179, Published online March 20, 2023, hereafter Tang).
Regarding claims 1, 10, and 19, McKinnon discloses a joint distraction system, a method for providing guidance during a surgical procedure, the method comprising, using one or more computing devices, and a processor configured to execute instructions stored in memory to provide guidance during a surgical procedure, wherein executing the instructions causes the processor to (McKinnon, Para 2; “The present disclosure relates generally to methods, systems, and apparatuses related to a computer-assisted surgical system that includes various hardware and software components that work together to enhance surgical workflows. The disclosed techniques may be applied to, for example, shoulder, hip, and knee arthroplasties, as well as other surgical interventions such as arthroscopic procedures, spinal procedures, maxillofacial procedures, rotator cuff procedures, ligament repair and replacement procedures. More particularly, the present disclosure relates to methods and systems for ligament balancing in a total or partial joint replacement surgical procedure.”):
obtain an image of patient anatomy including at least a femur and a pelvis (McKinnon, Para 46; “The CASS 100 can employ steps where the registration is verified using a probe that the surgeon precisely places on key areas of the proximal femur and pelvis identified for the surgeon on the display 125.”); segment the image into a pelvis portion and a femur portion (McKinnon, Para 36-39; “Any suitable tracking system can be used for tracking surgical objects and patient anatomy in the surgical theatre. For example, a combination of IR and visible light cameras can be used in an array. Various illumination sources, such as an IR LED light source, can illuminate the scene allowing three-dimensional imaging to occur. In some embodiments, this can include stereoscopic, tri-scopic, quad-scopic, etc. imaging. In addition to the camera array, which in some embodiments is affixed to a cart, additional cameras can be placed throughout the surgical theatre. For example, handheld tools or headsets worn by operators/surgeons can include imaging capability that communicates images back to a central processor to correlate those images with images captured by the camera array. This can give a more robust image of the environment for modeling using multiple perspectives […] specific objects can be manually registered by a surgeon with the system preoperatively or intraoperatively. For example, by interacting with a user interface, a surgeon may identify the starting location for a tool or a bone structure. By tracking fiducial marks associated with that tool or bone structure, or by using other conventional image tracking modalities, a processor may track that tool or bone as it moves through the environment in a three-dimensional model […] . The CASS 100 can compare and register the location data of bony landmarks collected by the surgeon with the probe with the location data of the same landmarks in the 3D model”);
generate a pre-operative plan for the surgical procedure using the segmented image wherein generating the pre-operative plan includes calculating, using the segmented image, (i) a surgical area of interest between the pelvis portion and the femur portion (joint displacement) (McKinnon, Para 51; “Preoperatively, the CASS 100 can develop a proposed surgical plan based on a three dimensional model of the hip joint and other information specific to the patient, such as the mechanical and anatomical axes of the leg bones, the epicondylar axis, the femoral neck axis, the dimensions (e.g., length) of the femur and hip, the midline axis of the hip joint, the ASIS axis of the hip joint, and the location of anatomical landmarks such as the lesser trochanter landmarks, the distal landmark, and the center of rotation of the hip joint.”) (McKinnon, Para 163-164; “Musculoskeletal simulation software may be used to perform a plurality of multi -body simulations based on a model of a joint for a particular patient or a group of patients. The joint model may be based on the properties determined using the finite element model described above. In some embodiments, a virtual joint distraction device may be introduced 815 into a model representing the joint space. In alternate embodiments, a joint distraction device, such as retractor 500, may be introduced 815 into the joint space of one or more test subjects and used 820 to provide a cantilever load stressing the joint. In some embodiments, simulation input factors that relate to the implementation of the joint distraction device may be provided 825 to the musculoskeletal simulator. Such simulation input factors may include, without limitation, a medial-lateral location of the tip of a joint distraction device, an anterior-posterior location of the tip of the joint distraction device, and a magnitude of a force applied to the joint distraction device. In some embodiments, simulation output responses may be recorded 830. Such simulation output responses may include, without limitation, a joint displacement, one or more joint contact forces, and joint kinematic information.”), and (ii) a minimum distance to be maintained between the femur and the pelvis within the surgical area of interest (McKinnon, Para 163; “Such simulation output responses may include, without limitation, a joint displacement, one or more joint contact forces, and joint kinematic information”) (McKinnon, Para 163-164; "a virtual joint distraction device may be introduced 815 into a model representing the joint space.[...] simulation input factors that relate to the implementation of the joint distraction device may be provided 825 to the musculoskeletal simulator. Such simulation input factors may include, without limitation, [...] a joint displacement"); and
generate and provide, via a display, visual guidance for performing distraction during the surgical procedure, wherein the visual guidance is generated based on an amount of distraction required to achieve the minimum distance (McKinnon, Para 168; “Referring back to FIG. 7, the surgeon may intraoperatively use a navigated (i.e., tracked) joint distraction device to apply 710 a varus and/or a valgus stress to the joint. With the joint distraction device in place, the surgeon may move the joint through a full or partial range of motion. As a result, additional input factor information, such as the placement of the joint distraction device and a magnitude of the force applied to the joint distraction device throughout the range of motion may be determined and/or received 715. In some embodiments, additional input information pertaining to the location and orientation of the bones surrounding the patient’s joint may be determined during the range of motion assessment using, for example and without limitation, a surgical navigation system and tracking arrays attached to the bones.”) (McKinnon, Para 163-164; “Musculoskeletal simulation software may be used to perform a plurality of multi -body simulations based on a model of a joint for a particular patient or a group of patients. The joint model may be based on the properties determined using the finite element model described above. In some embodiments, a virtual joint distraction device may be introduced 815 into a model representing the joint space. In alternate embodiments, a joint distraction device, such as retractor 500, may be introduced 815 into the joint space of one or more test subjects and used 820 to provide a cantilever load stressing the joint. In some embodiments, simulation input factors that relate to the implementation of the joint distraction device may be provided 825 to the musculoskeletal simulator. Such simulation input factors may include, without limitation, a medial-lateral location of the tip of a joint distraction device, an anterior-posterior location of the tip of the joint distraction device, and a magnitude of a force applied to the joint distraction device. In some embodiments, simulation output responses may be recorded 830. Such simulation output responses may include, without limitation, a joint displacement, one or more joint contact forces, and joint kinematic information.”) (McKinnon, Para 169; “Ligament response equation outputs, including outputs pertaining to joint kinematics and ligament strain, may be determined 720 based on the received information and the preoperatively assigned input factors. Based on the combination of the known inputs and the output responses, ligament tissue properties for the patient’s joint, such as ligament strain and ligament displacement, may also be determined 725.”).
A person having ordinary skill in the art would understand that the insertion of a joint distraction device is a type of joint distraction which achieves a minimum joint distance.
McKinnon does not clearly and explicitly disclose wherein the calculated minimum distance is a required minimum distance.
In an analogous hip joint replacement field of endeavor Tang discloses wherein a calculated minimum distance is a required minimum distance (Tang, Pg 1216, Conclusion; "The present study demonstrated that successful access to the CC was associated with greater distraction of the hip. An increase of the lateral gap by .2.2 times during the preoperative unsterile traction test without joint distention could predict a successful CC access.") (Tang, Abstract; "Background: Sufficient distraction of the hip is the key to a safe central compartment (CC) approach […] However, an adequate distraction gap has not been scientifically identified. Purpose: To determine the sufficient amount of distraction that could predict a successful CC access as well as to identify the risk factors for a failed or difficult CC access.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnon wherein the calculated minimum distance is a required minimum distance in order to allow for safe operation on the hip and in order to allow for assessment of hip damage before replacement as taught by Tang (Tang, Conclusion, Abstract).
Regarding claims 2 and 11, McKinnon as modified by Tang above discloses all of the limitations of claims 1 and 10 as discussed above.
McKinnon further discloses wherein the visual guidance includes instructions associated with at least one of an angle of the femur relative to the pelvis, a distraction amount, and a force to be applied to the patient anatomy (McKinnon, Para 168; “As a result, additional input factor information, such as the placement of the joint distraction device and a magnitude of the force applied to the joint distraction device throughout the range of motion may be determined and/or received 715. In some embodiments, additional input information pertaining to the location and orientation of the bones surrounding the patient’s joint may be determined during the range of motion assessment using, for example and without limitation, a surgical navigation system and tracking arrays attached to the bones”).
Regarding claims 3 and 12, McKinnon as modified by Tang above discloses all of the limitations of claims 1 and 10 as discussed above.
McKinnon further discloses generating the visual guidance (McKinnon, Para 52; “CASS 100 can provide the surgeon with options for different surgical workflows that will be displayed to the surgeon based on a surgeon’s preference. For example, the surgeon can choose from different workflows based on the number and types of anatomical landmarks that are checked and captured and/or the location and number of tracker arrays used in the registration process”) (McKinnon, Para 131; “The CASS 100 can track and record various actions and activities of the surgeon during each step of the surgery and compare actual activity to the pre-operative or intraoperative surgical plan. In some embodiments, a software tool may be employed to process this data into a format where the surgery can be effectively“played-back.” For example, in one embodiment, one or more GUIs may be used that depict all of the information presented on the Display 125 during surgery. This can be supplemented with graphs and images that depict the data collected by different tools. For example, a GUI that provides a visual depiction of the knee during tissue resection may provide the measured torque and displacement of the resection equipment adjacent to the visual depiction to better provide an understanding of any deviations that occurred from the planned resection area.”) based on detection of a fiducial marker arranged within the patient anatomy (McKinnon, Para 37-40; “specific objects can be manually registered by a surgeon with the system preoperatively or intraoperatively. For example, by interacting with a user interface, a surgeon may identify the starting location for a tool or a bone structure. By tracking fiducial marks associated with that tool or bone structure, or by using other conventional image tracking modalities, a processor may track that tool or bone as it moves through the environment in a three-dimensional mode […] certain markers, such as fiducial marks that identify individuals, important tools, or bones in the theater may include passive or active identifiers that can be picked up by a camera or camera array associated with the tracking system […] certain features of objects can be tracked by registering physical properties of the object and associating them with objects that can be tracked, such as fiducial marks fixed to a tool or bone. For example, a surgeon may perform a manual registration process whereby a tracked tool and a tracked bone can be manipulated relative to one another. By impinging the tip of the tool against the surface of the bone, a three-dimensional surface can be mapped for that bone that is associated with a position and orientation relative to the frame of reference of that fiducial mark. By optically tracking the position and orientation (pose) of the fiducial mark associated with that bone, a model of that surface can be tracked with an environment through extrapolation.”).
Regarding claims 4 and 13, McKinnon as modified by Tang above discloses all of the limitations of claims 1 and 10 as discussed above.
McKinnon further discloses capturing the image of the patient anatomy and storing the image (McKinnon, Para 75; “Data acquired during the pre-operative phase generally includes all information collected or generated prior to the surgery. Thus, for example, information about the patient may be acquired from a patient intake form or electronic medical record (EMR). Examples of patient information that may be collected include, without limitation, patient demographics, diagnoses, medical histories, progress notes, vital signs, medical history information, allergies, and lab results. The pre-operative data may also include images related to the anatomical area of interest.”) (McKinnon, Para 73; “In other embodiments, pre-operative images or other input data may be used to develop a robust plan preoperatively that is simply executed during surgery. In this case, the data collected by the CASS 100 during surgery may be used to make recommendations that ensure that the surgeon stays within the pre-operative surgical plan. For example, if the surgeon is unsure how to achieve a certain prescribed cut or implant alignment, the Surgical Computer 150 can be queried for a recommendation. In still other embodiments, the pre operative and intra-operative planning approaches can be combined such that a robust pre operative plan can be dynamically modified, as necessary or desired, during the surgical procedure. In some embodiments, a biomechanics-based model of patient anatomy contributes simulation data to be considered by the CASS 100 in developing preoperative, intraoperative, and post-operative/rehabilitation procedures to optimize implant performance outcomes for the patient.”) (McKinnon, Para 124; “Prior to surgery, the Patient Data 310, 315 and Healthcare Professional Data 325 may be captured and stored in a cloud-based or online database (e.g., the Surgical Data Server 180 shown in FIG. 2C). Information relevant to the procedure is supplied to a computing system via wireless data transfer or manually with the use of portable media storage”) (McKinnon, Para 97-102; describing the data storage).
Regarding claims 5 and 14, McKinnon as modified by Tang above discloses all of the limitations of claims 4 and 13 as discussed above.
McKinnon further discloses obtaining the image by retrieving the image from memory (McKinnon, Para 75; “Data acquired during the pre-operative phase generally includes all information collected or generated prior to the surgery. Thus, for example, information about the patient may be acquired from a patient intake form or electronic medical record (EMR). Examples of patient information that may be collected include, without limitation, patient demographics, diagnoses, medical histories, progress notes, vital signs, medical history information, allergies, and lab results. The pre-operative data may also include images related to the anatomical area of interest.”) (McKinnon, Para 73; “In other embodiments, pre-operative images or other input data may be used to develop a robust plan preoperatively that is simply executed during surgery. In this case, the data collected by the CASS 100 during surgery may be used to make recommendations that ensure that the surgeon stays within the pre-operative surgical plan. For example, if the surgeon is unsure how to achieve a certain prescribed cut or implant alignment, the Surgical Computer 150 can be queried for a recommendation. In still other embodiments, the pre operative and intra-operative planning approaches can be combined such that a robust pre operative plan can be dynamically modified, as necessary or desired, during the surgical procedure. In some embodiments, a biomechanics-based model of patient anatomy contributes simulation data to be considered by the CASS 100 in developing preoperative, intraoperative, and post-operative/rehabilitation procedures to optimize implant performance outcomes for the patient.”) (McKinnon, Para 124; “Prior to surgery, the Patient Data 310, 315 and Healthcare Professional Data 325 may be captured and stored in a cloud-based or online database (e.g., the Surgical Data Server 180 shown in FIG. 2C). Information relevant to the procedure is supplied to a computing system via wireless data transfer or manually with the use of portable media storage”) (McKinnon, Para 97-102; describing the data storage).
Regarding claims 6 and 15, McKinnon as modified by Tang above discloses all of the limitations of claims 1 and 10 as discussed above.
McKinnon further discloses wherein calculating the surgical area of interest includes calculating the surgical area of interest based on a location of an anatomical feature of at least one of the femur and the pelvis (McKinnon, Para 51; “Preoperatively, the CASS 100 can develop a proposed surgical plan based on a three dimensional model of the hip joint and other information specific to the patient, such as the mechanical and anatomical axes of the leg bones, the epicondylar axis, the femoral neck axis, the dimensions (e.g., length) of the femur and hip, the midline axis of the hip joint, the ASIS axis of the hip joint, and the location of anatomical landmarks such as the lesser trochanter landmarks, the distal landmark, and the center of rotation of the hip joint.”) (McKinnon, Para 163-164; “Musculoskeletal simulation software may be used to perform a plurality of multi -body simulations based on a model of a joint for a particular patient or a group of patients. The joint model may be based on the properties determined using the finite element model described above. In some embodiments, a virtual joint distraction device may be introduced 815 into a model representing the joint space. In alternate embodiments, a joint distraction device, such as retractor 500, may be introduced 815 into the joint space of one or more test subjects and used 820 to provide a cantilever load stressing the joint. In some embodiments, simulation input factors that relate to the implementation of the joint distraction device may be provided 825 to the musculoskeletal simulator. Such simulation input factors may include, without limitation, a medial-lateral location of the tip of a joint distraction device, an anterior-posterior location of the tip of the joint distraction device, and a magnitude of a force applied to the joint distraction device. In some embodiments, simulation output responses may be recorded 830. Such simulation output responses may include, without limitation, a joint displacement, one or more joint contact forces, and joint kinematic information.”).
Regarding claims 7 and 16, McKinnon as modified by Tang above discloses all of the limitations of claims 1 and 10 as discussed above.
McKinnon further discloses wherein calculating the minimum distance includes calculating the minimum distance based on a surgical instrument to be used during the surgical procedure (McKinnon, Para 168; “Referring back to FIG. 7, the surgeon may intraoperatively use a navigated (i.e., tracked) joint distraction device to apply 710 a varus and/or a valgus stress to the joint. With the joint distraction device in place, the surgeon may move the joint through a full or partial range of motion. As a result, additional input factor information, such as the placement of the joint distraction device and a magnitude of the force applied to the joint distraction device throughout the range of motion may be determined and/or received 715. In some embodiments, additional input information pertaining to the location and orientation of the bones surrounding the patient’s joint may be determined during the range of motion assessment using, for example and without limitation, a surgical navigation system and tracking arrays attached to the bones.”) (McKinnon, Para 163-164; “Musculoskeletal simulation software may be used to perform a plurality of multi -body simulations based on a model of a joint for a particular patient or a group of patients. The joint model may be based on the properties determined using the finite element model described above. In some embodiments, a virtual joint distraction device may be introduced 815 into a model representing the joint space. In alternate embodiments, a joint distraction device, such as retractor 500, may be introduced 815 into the joint space of one or more test subjects and used 820 to provide a cantilever load stressing the joint. In some embodiments, simulation input factors that relate to the implementation of the joint distraction device may be provided 825 to the musculoskeletal simulator. Such simulation input factors may include, without limitation, a medial-lateral location of the tip of a joint distraction device, an anterior-posterior location of the tip of the joint distraction device, and a magnitude of a force applied to the joint distraction device. In some embodiments, simulation output responses may be recorded 830. Such simulation output responses may include, without limitation, a joint displacement, one or more joint contact forces, and joint kinematic information.”).
Regarding claims 9 and 18, McKinnon as modified by Tang above discloses all of the limitations of claims 1 and 10 as discussed above.
McKinnon further discloses controlling an actuator of a hip distraction system (McKinnon, Para 66; “A robotic arm 105 A may be used for holding the retractor. For example in one embodiment, the robotic arm 105 A may be moved into the desired position by the surgeon. At that point, the robotic arm 105 A may lock into place. In some embodiments, the robotic arm 105 A is provided with data regarding the patient’s position, such that if the patient moves, the robotic arm can adjust the retractor position accordingly”) (McKinnon, Para 163; “virtual joint distraction device may be introduced 815 into a model representing the joint space. In alternate embodiments, a joint distraction device, such as retractor 500, may be introduced 815 into the joint space of one or more test subjects and used 820 to provide a cantilever load stressing the joint”).
Regarding claim 20, McKinnon as modified by Tang above discloses all of the limitations of claim 19 as discussed above.
McKinnon further discloses wherein the one or more computing devices are further configured to receive, from an imagine device, registration data corresponding to the patient anatomy and provide the visual guidance further based on the registration data (McKinnon, Para 40; “The registration process that registers the CASS 100 to the relevant anatomy of the patient can also involve the use of anatomical landmarks, such as landmarks on a bone or cartilage. For example, the CASS 100 can include a 3D model of the relevant bone or joint and the surgeon can intraoperatively collect data regarding the location of bony landmarks on the patient’s actual bone using a probe that is connected to the CASS. Bony landmarks can include, for example, the medial malleolus and lateral malleolus, the ends of the proximal femur and distal tibia, and the center of the hip joint. The CASS 100 can compare and register the location data of bony landmarks collected by the surgeon with the probe with the location data of the same landmarks in the 3D model. Alternatively, the CASS 100 can construct a 3D model of the bone or joint without pre-operative image data by using location data of bony landmarks and the bone surface that are collected by the surgeon using a CASS probe or other means. The registration process can also include determining various axes of a joint. For example, for a TKA the surgeon can use the CASS 100 to determine the anatomical and mechanical axes of the femur and tibia. The surgeon and the CASS 100 can identify the center of the hip joint by moving the patient’s leg in a spiral direction (i.e., circumduction) so the CASS can determine where the center of the hip joint is located”) (McKinnon, Para 52; “the surgeon can choose from different workflows based on the number and types of anatomical landmarks that are checked and captured and/or the location and number of tracker arrays used in the registration process.”).
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon and Tang as applied to claims 1 and 10 above, and in further view of Angibaud et al. (US20230149090, hereafter Angibaud).
Regarding claims 8 and 17, McKinnon as modified by Tang above discloses all of the limitations of claims 1 and 10 as discussed above.
McKinnon does not clearly and explicitly disclose wherein calculating the minimum distance includes calculating a plurality of minimum distances at respective points within the surgical area of interest.
In an analogous joint surgery field of endeavor Angibaud discloses calculating a plurality of minimum distances at respective points within a surgical area of interest (Angibaud, Para 371; “where a particular data series of the plurality of data series may include a particular series of values defining a plurality of gaps between a first joint member and a second joint member at a plurality of angles during the range of motion of a particular joint”) (Angibaud, Para 179; “he CAS technology may be used to characterize the considered joint as defined by a set of intra-operative inputs including, but not limited to, data associated with the size of at least one implant, data associated with angular alignment, and data associated with soft-tissue in terms of gaps defined as the distance between a first bone and a second bone or in terms of laxity defined as a differential between gaps.”) (Angibaud, Para 240; “Such measurement may be performed by femoral condyle at several angles of flexion, thus providing a cartography of the gaps. The cartography of the gaps may be leveraged to plan the position and orientation of the implants for obtaining a properly aligned and balanced joint. During the planning phase, the management of the soft-tissue may be treated from a sole unidimensional point of view with no consideration for the impact of the 3D volume aspect of the joint on the unidimensional measurement.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnon wherein calculating the minimum distance includes calculating a plurality of minimum distances at respective points within the surgical area of interest in order to provide proper planning for a aligned and balanced joint as taught by Angibaud (Angibaud, Para 240).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
CN117576021A – discloses calculation of minimum gap width for joints but does not beat the priority date of the instant application
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 John Li whose telephone number is (313)446-4916. The examiner can normally be reached Monday to Thursday; 5:30 AM to 3:30 PM Eastern.
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/JOHN D LI/Primary Examiner, Art Unit 3798