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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-15, and 17-20 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by Dees(US 20210315640 A1).
Regarding claim 1, Dees discloses a system for robotic joint revision surgery comprising: a robot including a plurality of components coupled together, the plurality of components including: at least a robotic arm, the robot being configured to recognize or navigate one or more surgical tools, via the robotic arm, to remove a previous prosthetic joint from a patient ; and wherein, the one or more surgical tools are interchangeable in connection with the robotic arm(surgeons often utilize “tracking arrays” that are coupled to the surgical components in conjunction with surgical navigation systems when performing implant procedures, such as knee replacement procedures and knee replacement revision procedures. The tracking arrays allow the surgeon to accurately track the location of the surgical components, as well as the bones of a patient during the surgery. By knowing the physical location of the tracking array, a tracking system and its associated software are able to detect and calculate the position of the tracked component relative to a surgical plan image[0004]. FIG. 1 provides an illustration of an example computer-assisted surgical system (CASS) 100, according to some embodiments. As described in further detail in the sections that follow, the CASS uses computers, robotics, and imaging technology to aid surgeons in performing orthopedic surgery procedures such as total knee arthroplasty (TKA) or total hip arthroplasty (THA). For example, surgical navigation systems can aid surgeons in locating patient anatomical structures, guiding surgical instruments, and implanting medical devices with a high degree of accuracy. Surgical navigation systems such as the CASS 100 often employ various forms of computing technology to perform a wide variety of standard and minimally invasive surgical procedures and techniques. Moreover, these systems allow surgeons to more accurately plan, track and navigate the placement of instruments and implants relative to the body of a patient, as well as conduct pre-operative and intra-operative body imaging[0047]), and the one or more surgical tools include at least one of: a large diameter cutting wheel, an in-line cutting tip, a posterior curved cradle, a reciprocal saw, a long burr, a hemispherical or 1/3 trephine reamer, a small osteotome operable to chip away at cement, a curved osteotome, a vibrator attachment, a bonding rotary tool, a keel remover, a motion converter, a bone cement melter, or a tapered drill(A tool or an end effector 105B attached or integrated into a robotic arm 105A may include, without limitation, a burring device, a scalpel, a cutting device, a retractor, a joint tensioning device, or the like. In embodiments in which an end effector 105B is used, the end effector may be positioned at the end of the robotic arm 105A such that any motor control operations are performed within the robotic arm system. In embodiments in which a tool is used, the tool may be secured at a distal end of the robotic arm 105A, but motor control operation may reside within the tool itself[0078]).
Regarding claim 2, Dees discloses the system of claim 1, wherein the plurality of components includes a plurality of input devices which includes a plurality of sensors, a tracking ray, or a plurality of cameras(Like the surgical system 500 shown in FIG. 5A, the system 700 can be configured to collect data reflecting the position and movement of a patella through a range of motion of a knee that will be subject to a surgical procedure. The system 700 can include a surgical navigation system 710 and a marker reader 720, such as a camera[0187]. In a robotically-assisted THA, the patient's anatomy can be registered to the CASS 100 using CT or other image data, the identification of anatomical landmarks, tracker arrays attached to the patient's bones, and one or more cameras[0064]. The Tracking System 115 uses one or more sensors to collect real-time position data that locates the patient's anatomy and surgical instruments[0052]).
Regarding claim 3, Dees discloses the system of claim 2, wherein the plurality of input devices includes at least one of strain gauge, a tension gauge, or a patella tracking device(In some embodiments, the powered impaction device includes feedback sensors that gather data during instrument use, and send data to a computing device such as a controller within the device or the Surgical Computer 150. This computing device can then record the data for later analysis and use. Examples of the data that may be collected include, without limitation, sound waves, the predetermined resonance frequency of each instrument, reaction force or rebound energy from patient bone, location of the device with respect to imaging (e.g., fluoro, CT, ultrasound, MRI, etc.) registered bony anatomy, and/or external strain gauges on bones[0072]. In certain implementations, the surgical navigation system 510 can be configured to employ a patella tracking component 530[0168]).
Regarding claim 4, Dees discloses the system of claim 1, wherein the plurality of components includes one or more output devices which includes a display unit(The Display 125 provides graphical user interfaces (GUIs) that display images collected by the Tissue Navigation System 120 as well other information relevant to the surgery[0059]).
Regarding claim 5, Dees discloses the system of claim 4, wherein the one or more output devices is integral to other components of the plurality of components of the robot(The Effector Platform 105 can also include a cutting guide or jig 105D that is used to guide saws or drills used to resect tissue during surgery. Such cutting guides 105D can be formed integrally as part of the Effector Platform 105 or Robotic Arm 105A[0051]).
Regarding claim 6, Dees discloses the system of claim 4, wherein the one or more output devices are separate from other components of the plurality of components of the robot(The Tracking System 115, Tissue Navigation System 120, and Display 125 can similarly be connected to the Surgical Computer 150 using wired connections. Alternatively, the Tracking System 115, Tissue Navigation System 120, and Display 125 may connect to the Surgical Computer 150 using wireless technologies such as, without limitation, Wi-Fi, Bluetooth, Near Field Communication (NFC), or ZigBee][0061].[FIG. 1 - shows separate display system]).
Regarding claim 7, Dees discloses the system of claim 1, wherein the plurality of components includes a plurality of input devices which are integral to other components of the plurality of components of the robot(In certain implementations, the surgical navigation system 510 can be configured to employ a patella tracking component 530. The patella tracking component 530 can be configured and implemented as an integral system or component within the surgical navigation system 510 or as a standalone component that connects to the surgical navigation system 510[0168]).
Regarding claim 8, Dees discloses the system of claim 1, wherein the plurality of components include a plurality of input devices which are separate from other components of the plurality of components of the robot(In certain implementations, the surgical navigation system 510 can be configured to employ a patella tracking component 530. The patella tracking component 530 can be configured and implemented as an integral system or component within the surgical navigation system 510 or as a standalone component that connects to the surgical navigation system 510[0168]).
Regarding claims 9-12, the language describes parameters of a large cutting wheel, a reciprocal saw, a long burr, an adaptor bolt, and a slap hammer. However, these tools are claimed under a conditional statement of claim 1 and are not required in the system. Therefore, the prior art does not need to describe all of these limitations to satisfy the claim language.
Regarding claim 13, Dees discloses the system of claim 1, wherein the plurality of components includes a plurality of input devices and a processor configured to: receive a plurality of three-dimensional images of a limb of the patient having the previous prosthetic joint; generate a surgical plan based on the three-dimensional images; and execute instructions from a non-transitory computer readable medium in response to input from the plurality of input devices(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. The CASS-developed surgical plan can provide a recommended optimal implant size and implant position and orientation based on the three dimensional model of the hip joint and other information specific to the patient[0068]).
Regarding claim 14, Dees discloses the system of claim 13, wherein the processor is configured to make changes to the surgical plan in response to the input from the plurality of input devices(Furthermore, if the surgical system used to implement the case plan is robotically assisted (e.g., as with NAVIO® or the MAKO Rio), bone removal and bone morphology during the surgery can be monitored in real time. If the resections made during the procedure deviate from the surgical plan, the subsequent placement of additional components may be optimized by the processor taking into account the actual resections that have already been made[0145]).
Regarding claim 15, Dees discloses a method to perform a robotic joint revision surgery, the method comprising steps of: determining a surgical plan for removing previous prosthetic joint from a patient by using a robot having a robotic arm, the robotic arm configured to provide robot-assisted navigation based on the surgical plan; operating at least one of: a large diameter cutting wheel in connection with the robotic arm to cut a first portion of the previous prosthetic joint; a long burr in connection with the robotic arm to break cement between a bone of the patient and the previous prosthetic joint; or operating a tapered drill in connection with the robotic arm to drill into a second portion of the previous prosthetic joint; attaching a hammer to the robotic arm; and extracting the second portion of the previous prosthetic joint via the slap hammer(Surgeons often utilize “tracking arrays” that are coupled to the surgical components in conjunction with surgical navigation systems when performing implant procedures, such as knee replacement procedures and knee replacement revision procedures. The tracking arrays allow the surgeon to accurately track the location of the surgical components, as well as the bones of a patient during the surgery. By knowing the physical location of the tracking array, a tracking system and its associated software are able to detect and calculate the position of the tracked component relative to a surgical plan image[0004]. FIG. 1 provides an illustration of an example computer-assisted surgical system (CASS) 100, according to some embodiments. As described in further detail in the sections that follow, the CASS uses computers, robotics, and imaging technology to aid surgeons in performing orthopedic surgery procedures such as total knee arthroplasty (TKA) or total hip arthroplasty (THA). For example, surgical navigation systems can aid surgeons in locating patient anatomical structures, guiding surgical instruments, and implanting medical devices with a high degree of accuracy. Surgical navigation systems such as the CASS 100 often employ various forms of computing technology to perform a wide variety of standard and minimally invasive surgical procedures and techniques. Moreover, these systems allow surgeons to more accurately plan, track and navigate the placement of instruments and implants relative to the body of a patient, as well as conduct pre-operative and intra-operative body imaging[0047]. A tool or an end effector 105B attached or integrated into a robotic arm 105A may include, without limitation, a burring device, a scalpel, a cutting device, a retractor, a joint tensioning device, or the like. In embodiments in which an end effector 105B is used, the end effector may be positioned at the end of the robotic arm 105A such that any motor control operations are performed within the robotic arm system. In embodiments in which a tool is used, the tool may be secured at a distal end of the robotic arm 105A, but motor control operation may reside within the tool itself[0078]).
Regarding claim 17, Dees discloses the method of claim 15, further comprising: operating a reamer to cut around a stem of the previous prosthetic joint(Current Patient Data 310 can include, but is not limited to, activity level, preexisting conditions, comorbidities, prehab performance, health and fitness level, pre-operative expectation level (relating to hospital, surgery, and recovery), a Metropolitan Statistical Area (MSA) driven score, genetic background, prior injuries (sports, trauma, etc.), previous joint arthroplasty, previous trauma procedures, previous sports medicine procedures, treatment of the contralateral joint or limb, gait or biomechanical information (back and ankle issues), levels of pain or discomfort, care infrastructure information (payer coverage type, home health care infrastructure level, etc.), and an indication of the expected ideal outcome of the procedure[0235]. ] For a robotically-assisted THA, the CASS 100 can include one or more powered reamers connected or attached to a robotic arm 105A or end effector 105B that prepares the pelvic bone to receive an acetabular implant according to a surgical plan. The robotic arm 105A and/or end effector 105B can inform the surgeon and/or control the power of the reamer to ensure that the acetabulum is being resected (reamed) in accordance with the surgical plan. For example, if the surgeon attempts to resect bone outside of the boundary of the bone to be resected in accordance with the surgical plan, the CASS 100 can power off the reamer or instruct the surgeon to power off the reamer. The CASS 100 can provide the surgeon with an option to turn off or disengage the robotic control of the reamer. The display 125 can depict the progress of the bone being resected (reamed) as compared to the surgical plan using different colors. The surgeon can view the display of the bone being resected (reamed) to guide the reamer to complete the reaming in accordance with the surgical plan[0066]).
Regarding claim 18, Dees discloses the method of claim 15, further comprising: receiving, at the robot, a plurality of three-dimensional images of the patient, the plurality of three-dimensional images used to generate the surgical plan(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. The CASS-developed surgical plan can provide a recommended optimal implant size and implant position and orientation based on the three dimensional model of the hip joint and other information specific to the patient[0068]).
Regarding claim 19, Dees discloses the method of claim 15, further comprising: receiving input data, at the robot, via a plurality of input devices; and generating changes to the surgical plan based on the input data received from the plurality of input devices(Furthermore, if the surgical system used to implement the case plan is robotically assisted (e.g., as with NAVIO® or the MAKO Rio), bone removal and bone morphology during the surgery can be monitored in real time. If the resections made during the procedure deviate from the surgical plan, the subsequent placement of additional components may be optimized by the processor taking into account the actual resections that have already been made[0145]).
Regarding claim 20, Dees discloses a method for robotic joint revision, the method comprising steps of: determining a surgical plan for performing a robotic joint revision surgery of a previous prosthetic joint, the surgical plan including robot-assisted navigation by a robotic arm of a robot; operating a plurality of interchangeable surgical tools in connection with the robotic arm to perform the robotic joint revision surgery via the robot-assisted navigation and within parameters of the surgical plan; receiving input data, at the robot, via one or more input devices in connection with the robot; and generating, via the robot, one or more changes to the surgical plan in response to the input data(In a revision surgery, the surgeon may paint certain areas that contain anatomical defects to allow for better visualization and navigation of implant insertion. These defects can be identified based on analysis of the pre-operative images. For example, in one embodiment, each pre-operative image is compared to a library of images showing “healthy” anatomy (i.e., without defects). Any significant deviations between the patient's images and the healthy images can be flagged as a potential defect. Then, during surgery, the surgeon can be warned of the possible defect via a visual alert on the display 125 of the CASS 100. The surgeon can then paint the area to provide further detail regarding the potential defect to the Surgical Computer 150.[0165]. A tool or an end effector 105B attached or integrated into a robotic arm 105A may include, without limitation, a burring device, a scalpel, a cutting device, a retractor, a joint tensioning device, or the like. In embodiments in which an end effector 105B is used, the end effector may be positioned at the end of the robotic arm 105A such that any motor control operations are performed within the robotic arm system. In embodiments in which a tool is used, the tool may be secured at a distal end of the robotic arm 105A, but motor control operation may reside within the tool itself[0078]. Furthermore, if the surgical system used to implement the case plan is robotically assisted (e.g., as with NAVIO® or the MAKO Rio), bone removal and bone morphology during the surgery can be monitored in real time. If the resections made during the procedure deviate from the surgical plan, the subsequent placement of additional components may be optimized by the processor taking into account the actual resections that have already been made[0145]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 16 is rejected under 35 U.S.C. 103 as being unpatentable over Dees in view of ボニー ダニエル パトリック(JP 2017536169 A), herein referred to as Ref B.
Regarding claim 16, Dees discloses the method of claim 15, but fails to disclose wherein: the first portion is a tibial tray of the previous prosthetic joint, and the second portion is a keel of the previous prosthetic joint.
However, Ref B teaches “ The removal of the prosthesis can be done in a conventional manner using a navigation system, robot-assisted or articulated handheld system. Bone and / or bone cement removal can be performed using a navigation system, a robotic system, an articulated handheld system, and combinations thereof(see attached translation, Abstract). The collected coordinates are then best fit to a library of tibial trays, and the plane is calculated from the now registered tray shape in the space where the bottom of the tray is located. Subsequently, the cutter is placed in an approximate position where the plane exists so that the cutter removes material under the tibial tray, and the cutter locks in self-joining and tracking mode relative to the plane. Is made possible. The cutter is switched on and begins to carefully cut the plane in which the cutter orientation is locked, even when there is bone movement. The operator carefully cuts around the keel, possibly by reviewing feedback information with graphical attributes that identify the current position of the drill relative to the keel. When the cut around the keel is finished to the extent that the surgeon feels sufficient, the tibial tray is pulled, leaving behind a planar bone surface(see attached translation, page 4, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the patella tracking system of Dees with the joint replacement of Ref B. Doing so would specify the elements of a previous prosthetic joint that are included in the revision surgery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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, CARL LAYNO can be reached at (571) 272-4949. 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.
/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796