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 § 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.
Claims 1, 3-7, 9-11, 13, 15-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Weiman et al (US20240245474A1; hereinafter referred to as Weiman) in view of Millahn (US20200229876A1; hereinafter referred to as Millahn).
Regarding Claim 1, Weiman teaches a system comprising (“A surgery navigation system is disclosed for computer assisted navigation during surgery” [Abstract]):
a camera (“The camera tracking system 200 includes tracking cameras 204 which may be spaced apart stereo cameras configured with partially overlapping field-of-views.” [208]);
and a processor configured to: determine a location of a first marker attached to a spine of a patient (“providing navigation information to surgeons and/or surgical robots for computer assisted navigation during spinal surgery.” [0001], “A patient reference element 116 (DRB) has a plurality of tracking fiducials and is secured directly to the patient 210 (e.g., to a bone of the patient).” [0207]);
provide navigation information for a first implant based on the location of the first marker (“providing navigation information to surgeons and/or surgical robots for computer assisted navigation during spinal surgery.” [0001], “The camera tracking system 200 can have any suitable configuration of arm(s) 202 to move, orient, and support the tracking cameras 204 in a desired location, and may contain at least one processor operable to track location of an individual fiducial and pose of an array of fiducials of a reference element.” [0208], “As used herein, the term “pose” refers to the location (e.g., along 3 orthogonal axes) and/or the rotation angle (e.g., about the 3 orthogonal axes) of fiducials (e.g., DRB) relative to another fiducial (e.g., surveillance fiducial) and/or to a defined coordinate system (e.g., camera coordinate system, navigation coordinate system, etc.).” [0209]);
determine a location of a surveillance marker that has been attached to the implant (“A reference element 170 is attached or formed on an instrument, surgical tool, surgical implant device, etc.” [0207] “The camera tracking system 200 can have any suitable configuration of arm(s) 202 to move, orient, and support the tracking cameras 204 in a desired location, and may contain at least one processor operable to track location of an individual fiducial and pose of an array of fiducials of a reference element.” [0208], “As used herein, the term “pose” refers to the location (e.g., along 3 orthogonal axes) and/or the rotation angle (e.g., about the 3 orthogonal axes) of fiducials (e.g., DRB) relative to another fiducial (e.g., surveillance fiducial) and/or to a defined coordinate system (e.g., camera coordinate system, navigation coordinate system, etc.).” [0209]);
monitor a second locational relationship between the first marker and the surveillance marker(“The camera tracking system 200 can have any suitable configuration of arm(s) 202 to move, orient, and support the tracking cameras 204 in a desired location, and may contain at least one processor operable to track location of an individual fiducial and pose of an array of fiducials of a reference element.” [0208], “As used herein, the term “pose” refers to the location (e.g., along 3 orthogonal axes) and/or the rotation angle (e.g., about the 3 orthogonal axes) of fiducials (e.g., DRB) relative to another fiducial (e.g., surveillance fiducial) and/or to a defined coordinate system (e.g., camera coordinate system, navigation coordinate system, etc.).” [0209]);
Weiman does not specifically disclose to determine a reference locational relationship between the first marker and the surveillance marker; and if the second locational relationship deviates from the reference locational relationship by more than a threshold value, perform one or more actions.
However, in a similar field of endeavor, Millahn teaches A method for providing positional relationship data, which represent the position of a marker device relative to a bone which it is affixed to, to a medical navigation system [Abstract].
Millahn also teaches to determine a reference locational relationship between the first marker and the surveillance marker (“A “reference star” refers to a device with a number of markers, advantageously three markers, attached to it, wherein the markers are (in particular detachably) attached to the reference star such that they are stationary, thus providing a known (and advantageously fixed) position of the markers relative to each other. The position of the markers relative to each other can be individually different for each reference star used within the framework of a surgical navigation, in order to enable the corresponding reference star to be identified by a surgical navigation system on the basis of the position of the markers relative to each other. It is therefore also then possible for the objects (for example, instruments and/or parts of a body) to which the reference star is attached to be identified and/or differentiated. In surgical navigation, the reference star serves to attach a plurality of markers to an object (for example, a bone or a medical instrument) in order to be able to detect the position of the object (i.e. its spatial location and/or alignment). Such a reference star in particular comprises a way of being attached to the object (for example, a clamp and/or a thread) and/or a holding element which ensures a distance between the markers and the object (in particular in order to assist the visibility of the markers to a marker detection device) and/or marker holders which are mechanically connected to the holding element and which the markers can be attached to.” [0016], “the current relative position between the bone and a medical instrument which bears the marker device is calculated from the bone registration data. In this step, a positional relationship between the structure of the bone and the marker device on the medical instrument is established.” [0020], “Instead of a cutting block, other medical instruments which are capable of bearing a marker device can be used to implement the method according to the present invention. Examples of other medical instruments include splints or implants.” [0071]);
and if the second locational relationship deviates from the reference locational relationship by more than a threshold value, perform one or more actions (“In Step c), an offset between the current relative position calculated in Step b) and a desired relative position is determined. The determination is preferably a calculation, but can also be a measurement.” [0021], “In Step d), indication information which is based on the determined offset is outputted. The indication information can be an indication information signal or indication information data. For example, the indication information can be optical information showing absolute values of the offset in up to three rotational and/or up to three translational dimensions. Other examples of indication information include optical, acoustic or tactile signals which indicate that the offset is below or above a threshold. Whether the offset is above or below the threshold can be determined on the basis of one or more rotational and/or translational components of the offset.” [0022]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Weiman as outlined above with to determine a reference locational relationship between the first marker and the surveillance marker; and if the second locational relationship deviates from the reference locational relationship by more than a threshold value, perform one or more actions as taught by Millahn, because it increases the efficiency and accuracy of surgical interventions and enables an operation to be documented by detecting and tracking the positions of body structures and medical instruments and by deriving information for the surgeon from these data [0003].
Regarding Claim 3, Weiman teaches that the camera is a stereoscopic camera (“The camera tracking system 200 includes tracking cameras 204 which may be spaced apart stereo cameras” [0208])
Regarding Claim 4, Weiman teaches that the processor is further configured to provide instructions to a user to perform a surgical procedure using the first marker (“During the intra-operative stage 1202, the spinal surgery navigation system 1220 uses a spinal surgery plan to provide navigated surgical assistance to the user, which may include displaying information and/or graphical indications to guide the user's actions, and/or provide instructions to guide a surgical robot 4 for precise plan execution.” [0057])
Regarding Claim 5, Weiman teaches all limitations noted above except that the processor being configured to perform the one or more actions comprises the processor being configured to one or more of stop providing instructions for the surgical procedure, alert the user, prompt the user to modify the location of the first marker, prompt the user to modify the location of the surveillance marker, and perform re- registration.
However, in a similar field of endeavor, Millahn teaches that the processor being configured to perform the one or more actions comprises the processor being configured to one or more of stop providing instructions for the surgical procedure, alert the user, prompt the user to modify the location of the first marker, prompt the user to modify the location of the surveillance marker, and perform re- registration (“Other examples of indication information include optical, acoustic or tactile signals which indicate that the offset is below or above a threshold. Whether the offset is above or below the threshold can be determined on the basis of one or more rotational and/or translational components of the offset. For example, the largest component of the offset can be compared to a threshold, or the average of one or more components of the offset can be compared to the threshold. In particular, Steps a) to d) are repeated until the offset is below the threshold.” [0022], “In Step e) of the method, bone reregistration data are received. Like the bone registration data, the bone reregistration data represent locations of points on the surface of the bone. The bone reregistration data therefore contain information about the position of the bone. The positional relationship, which represents the position of the marker device relative to the bone, is calculated from the bone reregistration data in Step f).” [0023]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Weiman as outlined above with the processor being configured to perform the one or more actions comprises the processor being configured to one or more of stop providing instructions for the surgical procedure, alert the user, prompt the user to modify a location of the first marker, prompt the user to modify a location of the surveillance marker, and perform re- registration as taught by Millahn, because it increases the efficiency and accuracy of surgical interventions and enables an operation to be documented by detecting and tracking the positions of body structures and medical instruments and by deriving information for the surgeon from these data [0003].
Regarding Claim 6, Weiman teaches that the processor being configured to provide the instructions to the user to perform the surgical procedure using the first marker comprises the processor being configured to provide navigation information for a second implant based on the location of the first marker (“The operation of the spinal surgery navigation system 1220 to generate the spinal surgery plan may include to process the pre-operative patient data through the machine learning model 1300 to output data indicating a planned access trajectory to access a target location on the spine of the defined-patient and/or data indicating a planned approach trajectory for implanting an implant device at the target location on the spine of the defined-patient.” [0066]).
Regarding Claim 7, Weiman teaches that the processor is configured to provide the navigation information for the first implant prior to connection of the surveillance marker to the first implant (“The operation of the spinal surgery navigation system 1220 to generate the spinal surgery plan may include to process the pre-operative patient data through the machine learning model 1300 to output data indicating a planned access trajectory to access a target location on the spine of the defined-patient and/or data indicating a planned approach trajectory for implanting an implant device at the target location on the spine of the defined-patient.” [0066]).
Regarding Claim 9, Weiman teaches that the processor is further configured to lock the location of the first marker (“A patient reference element 116 (DRB) has a plurality of tracking fiducials and is secured directly to the patient 210 (e.g., to a bone of the patient)” [0207]).
Regarding Claim 10, Weiman teaches that the processor is further configured to: determine that a second implant has been inserted into the spine of the patient; determine that a second surveillance marker has been attached to the second implant (“providing navigation information to surgeons and/or surgical robots for computer assisted navigation during spinal surgery.” [0001], “The operation of the spinal surgery navigation system 1220 to generate the spinal surgery plan may include to process the pre-operative patient data through the machine learning model 1300 to output data indicating a planned access trajectory to access a target location on the spine of the defined-patient and/or data indicating a planned approach trajectory for implanting an implant device at the target location on the spine of the defined-patient.” [0066], “After the patient surgical procedure has been completed (end patient case), post-operative data is collected 1414 and is provided as post-operative feedback for training the machine learning spine model 1404. The post-operative data can include, but is not limited to, any one or more of the following: deviation of spinal surgery plan versus actual placement of implants” [0161], “The camera tracking system 200 can have any suitable configuration of arm(s) 202 to move, orient, and support the tracking cameras 204 in a desired location, and may contain at least one processor operable to track location of an individual fiducial and pose of an array of fiducials of a reference element.” [0208], “As used herein, the term “pose” refers to the location (e.g., along 3 orthogonal axes) and/or the rotation angle (e.g., about the 3 orthogonal axes) of fiducials (e.g., DRB) relative to another fiducial (e.g., surveillance fiducial) and/or to a defined coordinate system (e.g., camera coordinate system, navigation coordinate system, etc.).” [0209], implanting multiple spinal implants as indicated in [0161] inherently requires the same process of registering the surveillance marker and first marker)
Weiman does not specifically teach determining an updated reference locational relationship between the first marker and the surveillance marker.
However, in a similar field of endeavor, Millahn teaches determining an updated reference locational relationship between the first marker and the surveillance marker (“A “reference star” refers to a device with a number of markers, advantageously three markers, attached to it, wherein the markers are (in particular detachably) attached to the reference star such that they are stationary, thus providing a known (and advantageously fixed) position of the markers relative to each other. The position of the markers relative to each other can be individually different for each reference star used within the framework of a surgical navigation, in order to enable the corresponding reference star to be identified by a surgical navigation system on the basis of the position of the markers relative to each other. It is therefore also then possible for the objects (for example, instruments and/or parts of a body) to which the reference star is attached to be identified and/or differentiated. In surgical navigation, the reference star serves to attach a plurality of markers to an object (for example, a bone or a medical instrument) in order to be able to detect the position of the object (i.e. its spatial location and/or alignment). Such a reference star in particular comprises a way of being attached to the object (for example, a clamp and/or a thread) and/or a holding element which ensures a distance between the markers and the object (in particular in order to assist the visibility of the markers to a marker detection device) and/or marker holders which are mechanically connected to the holding element and which the markers can be attached to.” [0016] “the current relative position between the bone and a medical instrument which bears the marker device is calculated from the bone registration data. In this step, a positional relationship between the structure of the bone and the marker device on the medical instrument is established.” [0020], “Instead of a cutting block, other medical instruments which are capable of bearing a marker device can be used to implement the method according to the present invention. Examples of other medical instruments include splints or implants.” [0071]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Weiman as outlined above with determining an updated reference locational relationship between the first marker and the surveillance marker as taught by Millahn, because it increases the efficiency and accuracy of surgical interventions and enables an operation to be documented by detecting and tracking the positions of body structures and medical instruments and by deriving information for the surgeon from these data [0003].
Regarding Claim 11, Millahn teaches a method comprising (“A surgery navigation system is disclosed for computer assisted navigation during surgery” [Abstract], “Some other embodiments are directed to a corresponding method by a surgery navigation system for computer assisted navigation during surgery” [0006]):
determining a location of a first marker attached to a spine of a patient (“providing navigation information to surgeons and/or surgical robots for computer assisted navigation during spinal surgery.” [0001], “A patient reference element 116 (DRB) has a plurality of tracking fiducials and is secured directly to the patient 210 (e.g., to a bone of the patient).” [0207]);
providing navigation information for a first implant based on the location of the first marker (“providing navigation information to surgeons and/or surgical robots for computer assisted navigation during spinal surgery.” [0001], “The camera tracking system 200 can have any suitable configuration of arm(s) 202 to move, orient, and support the tracking cameras 204 in a desired location, and may contain at least one processor operable to track location of an individual fiducial and pose of an array of fiducials of a reference element.” [0208], “As used herein, the term “pose” refers to the location (e.g., along 3 orthogonal axes) and/or the rotation angle (e.g., about the 3 orthogonal axes) of fiducials (e.g., DRB) relative to another fiducial (e.g., surveillance fiducial) and/or to a defined coordinate system (e.g., camera coordinate system, navigation coordinate system, etc.).” [0209]);
determining a location of a surveillance marker that has been attached to the implant (“A reference element 170 is attached or formed on an instrument, surgical tool, surgical implant device, etc.” [0207] “The camera tracking system 200 can have any suitable configuration of arm(s) 202 to move, orient, and support the tracking cameras 204 in a desired location, and may contain at least one processor operable to track location of an individual fiducial and pose of an array of fiducials of a reference element.” [0208], “As used herein, the term “pose” refers to the location (e.g., along 3 orthogonal axes) and/or the rotation angle (e.g., about the 3 orthogonal axes) of fiducials (e.g., DRB) relative to another fiducial (e.g., surveillance fiducial) and/or to a defined coordinate system (e.g., camera coordinate system, navigation coordinate system, etc.).” [0209]);
monitoring a second locational relationship between the first marker and the surveillance marker(“The camera tracking system 200 can have any suitable configuration of arm(s) 202 to move, orient, and support the tracking cameras 204 in a desired location, and may contain at least one processor operable to track location of an individual fiducial and pose of an array of fiducials of a reference element.” [0208], “As used herein, the term “pose” refers to the location (e.g., along 3 orthogonal axes) and/or the rotation angle (e.g., about the 3 orthogonal axes) of fiducials (e.g., DRB) relative to another fiducial (e.g., surveillance fiducial) and/or to a defined coordinate system (e.g., camera coordinate system, navigation coordinate system, etc.).” [0209]);
Weiman does not specifically disclose determining a reference locational relationship between the first marker and the surveillance marker; and if the second locational relationship deviates from the reference locational relationship by more than a threshold value, perform one or more actions.
However, in a similar field of endeavor, Millahn teaches A method for providing positional relationship data, which represent the position of a marker device relative to a bone which it is affixed to, to a medical navigation system [Abstract].
Millahn also teaches determining a reference locational relationship between the first marker and the surveillance marker (“the current relative position between the bone and a medical instrument which bears the marker device is calculated from the bone registration data. In this step, a positional relationship between the structure of the bone and the marker device on the medical instrument is established.” [0020], “Instead of a cutting block, other medical instruments which are capable of bearing a marker device can be used to implement the method according to the present invention. Examples of other medical instruments include splints or implants.” [0071]);
and if the second locational relationship deviates from the reference locational relationship by more than a threshold value, perform one or more actions (“In Step c), an offset between the current relative position calculated in Step b) and a desired relative position is determined. The determination is preferably a calculation, but can also be a measurement.” [0021], “In Step d), indication information which is based on the determined offset is outputted. The indication information can be an indication information signal or indication information data. For example, the indication information can be optical information showing absolute values of the offset in up to three rotational and/or up to three translational dimensions. Other examples of indication information include optical, acoustic or tactile signals which indicate that the offset is below or above a threshold. Whether the offset is above or below the threshold can be determined on the basis of one or more rotational and/or translational components of the offset.” [0022]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Weiman as outlined above with determining a reference locational relationship between the first marker and the surveillance marker; and if the second locational relationship deviates from the reference locational relationship by more than a threshold value, perform one or more actions as taught by Millahn, because it increases the efficiency and accuracy of surgical interventions and enables an operation to be documented by detecting and tracking the positions of body structures and medical instruments and by deriving information for the surgeon from these data [0003].
Regarding Claim 13, Weiman teaches that the location of the first marker and the location of the surveillance marker are determined based on images received from a stereoscopic camera (“The camera tracking system 200 includes tracking cameras 204 which may be spaced apart stereo cameras” [0208])
Regarding Claim 15, Weiman teaches all limitations noted above except that the processor being configured to perform the one or more actions comprises the processor being configured to one or more of stop providing instructions for the surgical procedure, alert the user, prompt the user to modify the location of the first marker, prompt the user to modify the location of the surveillance marker, and perform re- registration.
However, in a similar field of endeavor, Millahn teaches that the processor being configured to perform the one or more actions comprises the processor being configured to one or more of stop providing instructions for the surgical procedure, alert the user, prompt the user to modify the location of the first marker, prompt the user to modify the location of the surveillance marker, and perform re- registration (“Other examples of indication information include optical, acoustic or tactile signals which indicate that the offset is below or above a threshold. Whether the offset is above or below the threshold can be determined on the basis of one or more rotational and/or translational components of the offset. For example, the largest component of the offset can be compared to a threshold, or the average of one or more components of the offset can be compared to the threshold. In particular, Steps a) to d) are repeated until the offset is below the threshold.” [0022], “In Step e) of the method, bone reregistration data are received. Like the bone registration data, the bone reregistration data represent locations of points on the surface of the bone. The bone reregistration data therefore contain information about the position of the bone. The positional relationship, which represents the position of the marker device relative to the bone, is calculated from the bone reregistration data in Step f).” [0023]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Weiman as outlined above with the processor being configured to perform the one or more actions comprises the processor being configured to one or more of stop providing instructions for the surgical procedure, alert the user, prompt the user to modify the location of the first marker, prompt the user to modify the location of the surveillance marker, and perform re- registration as taught by Millahn, because it increases the efficiency and accuracy of surgical interventions and enables an operation to be documented by detecting and tracking the positions of body structures and medical instruments and by deriving information for the surgeon from these data [0003].
Regarding Claim 16, Weiman teaches providing navigation information for a second implant based on the location of the first marker (“The operation of the spinal surgery navigation system 1220 to generate the spinal surgery plan may include to process the pre-operative patient data through the machine learning model 1300 to output data indicating a planned access trajectory to access a target location on the spine of the defined-patient and/or data indicating a planned approach trajectory for implanting an implant device at the target location on the spine of the defined-patient.” [0066]).
Regarding Claim 17, Weiman teaches providing the navigation information for the first implant prior to connection of the surveillance marker to the first implant. (“The operation of the spinal surgery navigation system 1220 to generate the spinal surgery plan may include to process the pre-operative patient data through the machine learning model 1300 to output data indicating a planned access trajectory to access a target location on the spine of the defined-patient and/or data indicating a planned approach trajectory for implanting an implant device at the target location on the spine of the defined-patient.” [0066]).
Regarding Claim 19, Weiman teaches locking the location of the first marker (“A patient reference element 116 (DRB) has a plurality of tracking fiducials and is secured directly to the patient 210 (e.g., to a bone of the patient)” [0207]).
Regarding Claim 20, Weiman teaches determining that a second implant has been inserted into the spine of the patient; determining that a second surveillance marker has been attached to the second implant; and determining an updated reference locational relationship between the first marker and the surveillance marker (“providing navigation information to surgeons and/or surgical robots for computer assisted navigation during spinal surgery.” [0001], “The operation of the spinal surgery navigation system 1220 to generate the spinal surgery plan may include to process the pre-operative patient data through the machine learning model 1300 to output data indicating a planned access trajectory to access a target location on the spine of the defined-patient and/or data indicating a planned approach trajectory for implanting an implant device at the target location on the spine of the defined-patient.” [0066], “After the patient surgical procedure has been completed (end patient case), post-operative data is collected 1414 and is provided as post-operative feedback for training the machine learning spine model 1404. The post-operative data can include, but is not limited to, any one or more of the following: deviation of spinal surgery plan versus actual placement of implants” [0161], “The camera tracking system 200 can have any suitable configuration of arm(s) 202 to move, orient, and support the tracking cameras 204 in a desired location, and may contain at least one processor operable to track location of an individual fiducial and pose of an array of fiducials of a reference element.” [0208], “As used herein, the term “pose” refers to the location (e.g., along 3 orthogonal axes) and/or the rotation angle (e.g., about the 3 orthogonal axes) of fiducials (e.g., DRB) relative to another fiducial (e.g., surveillance fiducial) and/or to a defined coordinate system (e.g., camera coordinate system, navigation coordinate system, etc.).” [0209], implanting multiple spinal implants as indicated in [0161] inherently requires the same process of registering the surveillance marker and first marker)
Weiman does not specifically teach determining an updated reference locational relationship between the first marker and the surveillance marker.
However, in a similar field of endeavor, Millahn teaches determining an updated reference locational relationship between the first marker and the surveillance marker (“the current relative position between the bone and a medical instrument which bears the marker device is calculated from the bone registration data. In this step, a positional relationship between the structure of the bone and the marker device on the medical instrument is established.” [0020], “Instead of a cutting block, other medical instruments which are capable of bearing a marker device can be used to implement the method according to the present invention. Examples of other medical instruments include splints or implants.” [0071]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Weiman as outlined above with determining an updated reference locational relationship between the first marker and the surveillance marker as taught by Millahn, because it increases the efficiency and accuracy of surgical interventions and enables an operation to be documented by detecting and tracking the positions of body structures and medical instruments and by deriving information for the surgeon from these data [0003].
Claims 2, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Weiman in view of Millahn as applied to Claim 1, and further in view of Finley (US 20180092699 A1).
Regarding Claim 2, Weiman and Millahn teaches all limitation noted above except that the location of the first marker comprises one or more of a navigation array configured and adapted to connect to a spinous process of the patient and a navigation array configured and adapted to connect to an iliac crest of the patient.
However, in a similar field of endeavor, Finley teaches a system, including various apparatus and methods, for surgical navigation is provided. The system is configured to track the spine of a patient by capturing images via one or more cameras [Abstract].
Finley also teaches that the location of the first marker comprises one or more of a navigation array configured and adapted to connect to a spinous process of the patient and a navigation array configured and adapted to connect to an iliac crest of the patient (“FIGS. 9A-9C illustrate the use of a spine tracker inserter affixing a spine pin and an array to a spinous process in accordance with an embodiment of the navigation system.” [0040], “a first infrared camera 34 may capture and track spine tracker arrays 38 while a second infrared camera 34 captures and tracks the operative corridor and an array 38 affixed to the iliac crest” [0128])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Weiman and Millahn as outlined above with the location of the first marker comprises one or more of a navigation array configured and adapted to connect to a spinous process of the patient and a navigation array configured and adapted to connect to an iliac crest of the patient as taught by Finley, because a need continues to exist for systems and methods that increase surgical efficiency [0003].
Regarding Claim 12, Weiman and Millahn teaches all limitation noted above except that the location of the first marker comprises one or more of a navigation array configured and adapted to connect to a spinous process of the patient and a navigation array configured and adapted to connect to an iliac crest of the patient.
However, in a similar field of endeavor, Finley teaches a system, including various apparatus and methods, for surgical navigation is provided. The system is configured to track the spine of a patient by capturing images via one or more cameras [Abstract].
Finley also teaches that the location of the first marker comprises one or more of a navigation array configured and adapted to connect to a spinous process of the patient and a navigation array configured and adapted to connect to an iliac crest of the patient (“FIGS. 9A-9C illustrate the use of a spine tracker inserter affixing a spine pin and an array to a spinous process in accordance with an embodiment of the navigation system.” [0040], “a first infrared camera 34 may capture and track spine tracker arrays 38 while a second infrared camera 34 captures and tracks the operative corridor and an array 38 affixed to the iliac crest” [0128])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Weiman and Millahn as outlined above with the location of the first marker comprises one or more of a navigation array configured and adapted to connect to a spinous process of the patient and a navigation array configured and adapted to connect to an iliac crest of the patient as taught by Finley, because a need continues to exist for systems and methods that increase surgical efficiency [0003].
Claims 8, 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Weiman in view of Millahn as applied to Claim 1, and further in view of Johnson et al (US 20230277084 A1; hereinafter referred to as Johnson).
Regarding Claim 8, Weiman and Millahn teaches all limitations noted above except that the reference locational relationship comprises a distance between the first marker and the surveillance marker along a vector.
However, in a similar field of endeavor, Johnson teaches an instrument that is navigated within the targeted anatomical structure. The instrument includes a tracking array, and a relative position of the instrument within the targeted anatomical structure is determined by the tracking array [Abstract].
Johnson also teaches that the reference locational relationship comprises a distance between the first marker and the surveillance marker along a vector (“FIG. 15D shows the end-effector of FIG. 15A with the instrument in the guide tube at two different frames and its relative distance to the single tracking marker on the guide tube;” [0030], “information about the position of the end effector 112 from such an array 612 and information about the location of a target trajectory from another tracked source are used to calculate the required moves that must be input for each axis of the robot 102 that will move the guide tube 114 into alignment with the trajectory and move the tip to a particular location along the trajectory vector.” [0098]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Weiman and Millahn as outlined above with the reference locational relationship comprises a distance between the first marker and the surveillance marker along a vector as taught by Johnson, because It would be desirable to provide a more dependable way for a surgeon to ensure that a targeted anatomical structure is sufficiently clear [0004].
Regarding Claim 14, Weiman and Millahn teaches all limitations noted above except that the reference locational relationship comprises one or more of a distance, a vector, and 3-dimensional (3D) points.
However, in a similar field of endeavor, Johnson teaches that the reference locational relationship comprises one or more of a distance, a vector, and 3-dimensional (3D) points (“FIG. 15D shows the end-effector of FIG. 15A with the instrument in the guide tube at two different frames and its relative distance to the single tracking marker on the guide tube;” [0030], “information about the position of the end effector 112 from such an array 612 and information about the location of a target trajectory from another tracked source are used to calculate the required moves that must be input for each axis of the robot 102 that will move the guide tube 114 into alignment with the trajectory and move the tip to a particular location along the trajectory vector.” [0098]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Weiman and Millahn as outlined above with the reference locational relationship comprises one or more of a distance, a vector, and 3-dimensional (3D) points as taught by Johnson, because It would be desirable to provide a more dependable way for a surgeon to ensure that a targeted anatomical structure is sufficiently clear [0004].
Regarding Claim 18, Weiman and Millahn teaches all limitations noted above except that the reference locational relationship comprises a distance between the first marker and the surveillance marker along a vector.
However, in a similar field of endeavor, Johnson teaches an instrument that is navigated within the targeted anatomical structure. The instrument includes a tracking array, and a relative position of the instrument within the targeted anatomical structure is determined by the tracking array [Abstract].
Johnson also teaches that the reference locational relationship comprises a distance between the first marker and the surveillance marker along a vector (“FIG. 15D shows the end-effector of FIG. 15A with the instrument in the guide tube at two different frames and its relative distance to the single tracking marker on the guide tube;” [0030], “information about the position of the end effector 112 from such an array 612 and information about the location of a target trajectory from another tracked source are used to calculate the required moves that must be input for each axis of the robot 102 that will move the guide tube 114 into alignment with the trajectory and move the tip to a particular location along the trajectory vector.” [0098]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Weiman and Millahn as outlined above with the reference locational relationship comprises a distance between the first marker and the surveillance marker along a vector as taught by Johnson, because It would be desirable to provide a more dependable way for a surgeon to ensure that a targeted anatomical structure is sufficiently clear [0004].
Response to Arguments
Applicant's arguments filed 09/22/2025 have been fully considered but they are not persuasive.
Regarding the U.S.C. 103 rejection of Claims 1 & 11 the applicant argues the following:
The cited references, alone or in combination, do not teach or disclose at least the above- noted language. The Office Action acknowledges that Weiman does not disclose the "determine a reference locational relationship" and "perform one or more actions" elements noted above, but alleges that Millahn does. However, the cited portions of Millahn-specifically, paragraph [0020]-discloses determining "a positional relationship between the structure of the bone and the marker device on the medical instrument" (emphasis added). That paragraph also notes that "the current relative position between the bone and a medical instrument which bears the marker device is calculated from the bone registration data." Thus, rather than disclosing a relationship between two markers, as in claims 1 and 11, Millahn discloses a relationship between a marker and a bone. Millahn therefore does not disclose the "determine a reference locational relationship" element of the independent claims.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
However, the combination of Weiman and Millahan discloses the above limitation. Weiman discloses using referential markers on both the bone of a patient and a surgical device (“A patient reference element 116 (DRB) has a plurality of tracking fiducials and is secured directly to the patient 210 (e.g., to a bone of the patient). A reference element 170 is attached or formed on an instrument, surgical tool, surgical implant device, etc.” [0207])
While Millahan discloses monitoring the positional relationship between a bone and a surgical device (“the current relative position between the bone and a medical instrument which bears the marker device is calculated from the bone registration data. In this step, a positional relationship between the structure of the bone and the marker device on the medical instrument is established.” [0020], “Instead of a cutting block, other medical instruments which are capable of bearing a marker device can be used to implement the method according to the present invention. Examples of other medical instruments include splints or implants.” [0071])
It is also noted that Millahan discloses the spatial structure and positioning of the bone is determined by markers (“The position of the markers relative to each other can be individually different for each reference star used within the framework of a surgical navigation, in order to enable the corresponding reference star to be identified by a surgical navigation system on the basis of the position of the markers relative to each other. It is therefore also then possible for the objects (for example, instruments and/or parts of a body) to which the reference star is attached to be identified and/or differentiated. In surgical navigation, the reference star serves to attach a plurality of markers to an object (for example, a bone or a medical instrument) in order to be able to detect the position of the object (i.e. its spatial location and/or alignment). Such a reference star in particular comprises a way of being attached to the object (for example, a clamp and/or a thread) and/or a holding element which ensures a distance between the markers and the object (in particular in order to assist the visibility of the markers to a marker detection device) and/or marker holders which are mechanically connected to the holding element and which the markers can be attached to.” [0016])
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure (US20160166335A1, US20210059770A1).
THIS ACTION IS MADE FINAL. 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 STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th 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
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797