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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-15 in the reply filed on 12/13/2025 is acknowledged. Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Thus, claims 1-15 are presently pending in this application.
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.
Claims 1-7 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (2016/0029952) in view of Singh et al. (2015/0297362) “Singh”.
Regarding claim 1, Hunter discloses a system 10 (Fig. 4) comprising: an instrumented femoral head 18 comprising: a set of inertial sensors 22 (Fig. 4) configured to output a second series of orientation data representing orientations of the instrumented femoral head (par. 0057 discloses the femoral head 18 comprises sensors 22 which detect orientation of the femoral head with respect to the acetabular liner);
a reference module 22 (sensors 22 of shell 12; Fig. 4) configured to: couple to a pelvis of a patient (sensors 22 are coupled to the acetabular shell 12 which is attached to the pelvis; Fig. 5); and output a third series of reference orientation data representing orientations of the pelvis (par. 0056 discloses the sensors 22 detect orientation of the shell 12 with respect to the pelvic bone); and a controller 126 (Fig. 12) configured to: access the second series of orientation data, and the third series of reference orientation data (par. 0089 discloses the control unit 126 in communication with the sensors); calculate a first sequence of orientations of the instrumented femoral head relative the pelvis based on the second series of orientation data and the third series of reference orientation data (par. 0018, 0084, 0093 discloses processing sensor data to determine the joint range of motion);
Hunter is silent regarding the instrumented femoral head comprising a shank configured to seat on a proximal end of a neck of a femoral stem component installed on a proximal end of a femur and a spherical shell arranged over the shank; a set of force sensors configured to output: a first series of force data representing forces acting on the spherical shell; controller configured to: access the first series of force data; and based on the first sequence of orientations of the instrumented femoral head and the first series of force data, calculate a first force versus angular orientation curve representing forces exerted on the instrumented femoral head by an acetabulum in the pelvis over a first range of motion of the femur.
However, Singh teaches a similar system 200 (Fig. 2A) comprising an instrumented femoral head 216 (Fig. 6C) comprising a shank 602 configured to seat on a proximal end of a neck of a femoral stem component (Fig. 6C discloses the shank 602 is capable of seating on a neck end via articular surface 601) installed on a proximal end of a femur 200 (Fig. 6C) and a spherical shell 601 arranged over the shank 602; a set of force sensors 233a-f configured to output: a first series of force data representing forces acting on the spherical shell (par. 0058); a set of inertial sensors 221 (pars. 0042 0058 discloses inertial measurement unit 221) configured to output a second series of orientation data representing orientations of the instrumented femoral head (par. 0042); a controller 310 (Fig. 5) configured to: access the first series of force data 230; access the second series of orientation data 221 and based on the first sequence of orientations of the instrumented femoral head and the first series of force data, calculate a first force versus angular orientation curve representing forces exerted on the instrumented femoral head by an acetabulum in the pelvis over a first range of motion of the femur. (par. 0042 discloses the inertial measurement unit 221 calculates the positions of the femur with respect to the pelvis; par. 0010 discloses the force sensing module is integrated with the inertial measurement unit; and Fig. 11 and par. 0083 disclose the force versus angular orientation data over a range of motion).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Hunter to include the instrumented femoral head comprising a shank configured to seat on a proximal end of a neck of a femoral stem component installed on a proximal end of a femur and a spherical shell arranged over the shank; a set of force sensors configured to output: a first series of force data representing forces acting on the spherical shell; controller configured to: access the first series of force data; and based on the first sequence of orientations of the instrumented femoral head and the first series of force data, calculate a first force versus angular orientation curve representing forces exerted on the instrumented femoral head by an acetabulum in the pelvis over a first range of motion of the femur, as taught and suggested by Singh, for allowing the surgeons the ability to evaluate orthopedic performance by measuring kinematic and kinetic parameters simultaneously (par. 0006 of Singh).
Regarding claims 2-4, Hunter discloses the claimed system of claim 1; except for wherein the instrumented femoral head further comprises a communication module: arranged in the shank; and configured to transmit the first series of force data, the second series of orientation data, and the third series of reference orientation data to the controller; wherein the shank defines an external support surface; wherein the spherical shell defines an internal contact surface facing the external contact surface of the shank; and wherein the set of force sensors are interposed between the external contract surf ace of the shank and the internal contract surface of the spherical shell; locate the spherical shell over the shank; and communicate forces exerted on the instrumented femoral head by the acetabulum from the spherical shell onto the shank; and wherein the external support surface of the shank comprises a base and a side; and wherein the set of force sensors comprises: a first force sensor arranged on the base of the external support surface shank; a second force sensor arranged on the side of the external support surface and proximal a longitudinal axis of the shank; a third force sensor arranged on the side of the external support surface opposite the second force sensor and proximal the longitudinal axis of the shank; a fourth force sensor arranged on the side of the external support surface and proximal a lateral axis of the shank; and a fifth force sensor arranged on the side of the external support surface opposite the fourth force sensor and proximal the lateral axis of the shank; and wherein the external support surface of the shank comprises a semi-spherical external support surface; and wherein the set of force sensors comprises a first force sensor, a second force sensor, and a third force sensor arranged on the semi-spherical external support surface and angularly spaced about a parallel of the semi-spherical external support surface, the parallel interposed between a proximal pole of the semispherical external support surface and an equator of the semi-spherical external support surface.
However, Singh teaches a similar system 200 (Fig. 2A) comprising an instrumented femoral head 216 (Fig. 6C) comprising a shank 602 wherein the instrumented femoral head further comprises a communication module (231/411; Fig. 5): arranged in the shank (Fig. 6C discloses the communication module 231 and 411 which is part of 221 are in the shank); and configured to transmit the first series of force data, the second series of orientation data (par. 0056 discloses microprocessors 231 and 411 provide wireless communications) and the third series of reference orientation data (when combined with Hunter) to the controller 310 (Fig. 5); wherein the shank defines an external support surface (external surface of 602; Fig. 6C) ; wherein the spherical shell 601 defines an internal contact surface facing the external contact surface of the shank (Fig. 6C);
and wherein the set of force sensors are interposed between the external contract surface of the shank and the internal contract surface of the spherical shell (sensors 233a-f are located between the shell 601 and shank 602 surfaces); locate the spherical shell over the shank (Fig. 6C); and communicate forces exerted on the instrumented femoral head by the acetabulum from the spherical shell onto the shank (par. 0059 discloses the forces on shell 601 are transferred to force sensors in the shank 602);
and wherein the external support surface of the shank comprises a base and a side (Fig. 6C); and wherein the set of force sensors comprises: a first force sensor 233f arranged on the base of the external support surface shank 602; a second force sensor 233a arranged on the side of the external support surface and proximal a longitudinal axis of the shank; a third force sensor 233c arranged on the side of the external support surface opposite the second force sensor and proximal the longitudinal axis of the shank; a fourth force sensor 233b arranged on the side of the external support surface and proximal a lateral axis of the shank; and a fifth force sensor 233e arranged on the side of the external support surface opposite the fourth force sensor and proximal the lateral axis of the shank (Fig. 6C discloses the force sensors 233a-f disposed around the shell 601);
wherein the external support surface of the shank comprises a semi-spherical external support surface 601 (par. 0059); and wherein the set of force sensors comprises a first force sensor, a second force sensor, and a third force sensor arranged on the semi-spherical external support surface and angularly spaced about a parallel of the semi-spherical external support surface, the parallel interposed between a proximal pole of the semispherical external support surface and an equator of the semi-spherical external support surface (sensors 233a-c are disposed on the parallel between a proximal pole and equator of the hemi-spherical external support surface 601; Fig. 6C).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Hunter to include the instrumented femoral head further comprises a communication module: arranged in the shank; and configured to transmit the first series of force data, the second series of orientation data, and the third series of reference orientation data to the controller; wherein the shank defines an external support surface; wherein the spherical shell defines an internal contact surface facing the external contact surface of the shank; and wherein the set of force sensors are interposed between the external contract surf ace of the shank and the internal contract surface of the spherical shell; locate the spherical shell over the shank; and communicate forces exerted on the instrumented femoral head by the acetabulum from the spherical shell onto the shank; and wherein the external support surface of the shank comprises a base and a side; and wherein the set of force sensors comprises: a first force sensor arranged on the base of the external support surface shank; a second force sensor arranged on the side of the external support surface and proximal a longitudinal axis of the shank; a third force sensor arranged on the side of the external support surface opposite the second force sensor and proximal the longitudinal axis of the shank; a fourth force sensor arranged on the side of the external support surface and proximal a lateral axis of the shank; and a fifth force sensor arranged on the side of the external support surface opposite the fourth force sensor and proximal the lateral axis of the shank; and wherein the external support surface of the shank comprises a semi-spherical external support surface; and wherein the set of force sensors comprises a first force sensor, a second force sensor, and a third force sensor arranged on the semi-spherical external support surface and angularly spaced about a parallel of the semi-spherical external support surface, the parallel interposed between a proximal pole of the semispherical external support surface and an equator of the semi-spherical external support surface, as taught and suggested by Singh, for allowing the surgeons the ability to evaluate orthopedic performance by measuring kinematic and kinetic parameters simultaneously (par. 0006 of Singh).
Regarding claim 5, Hunter discloses the claimed system of claim 1; except for wherein the set of inertial sensors of the instrumented femoral head comprises a first three-axis inertial measurement unit; wherein the set of force sensors comprises a set of piezoelectric load cells supporting the spherical shell on the shank; and wherein the reference module comprises a second three-axis inertial measurement unit. However, Singh teaches a similar system comprising the set of inertial sensors of the instrumented femoral head comprises a first three-axis inertial measurement unit; wherein the set of force sensors comprises a set of piezoelectric load cells supporting the spherical shell on the shank; and wherein the reference module comprises a second three-axis inertial measurement unit (par. 0068 discloses piezoresistive sensors 233 and par. 0042 discloses inertial measurement unit measures 3 dimensions).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Hunter to include wherein the set of inertial sensors of the instrumented femoral head comprises a first three-axis inertial measurement unit; wherein the set of force sensors comprises a set of piezoelectric load cells supporting the spherical shell on the shank; and wherein the reference module comprises a second three-axis inertial measurement unit, as taught and suggested by Singh, for allowing the surgeons the ability to evaluate orthopedic performance by measuring kinematic and kinetic parameters simultaneously (par. 0006 of Singh).
Regarding claims 6-7, Hunter discloses the claimed system of claim 1; except for wherein the instrumented femoral head: further comprises a transmitter; and is further configured to: at a first time, identify a first temporal pattern of force fluctuations in the first series of force data, the first temporal pattern comprising a set of force peaks within a force activation range and occurring within an activation time interval; in response to detecting the first temporal pattern: activate the transmitter; and trigger transmission of the first series of force data and the second series of orientation data, via the transmitter, to the controller; at a second time, identify a second temporal pattern of force fluctuations in the first series of force data, the second pattern different from the first temporal pattern; and o in response to detecting the second temporal pattern, cease transmission of the first series of force data and the second series of orientation data to the controller; the instrumented femoral head: further comprises a transmitter and a receiver; and is further configured to: at a first time, receive an activation signal from the controller via the receiver; in response to receiving the activation signal, trigger transmission of the first series of force data and the second series of orientation data to the controller via the transmitter; at a second time, receive a deactivation signal from the controller via the receiver; and in response to receiving the deactivation signal, cease transmission of the first series of force data and the second series of orientation data.
However, Singh teaches a similar system comprising the instrumented femoral head 216 (Fig. 6C): further comprises a transmitter (par. 0056 discloses microprocessors 231 and 411 provide wireless communications; Fig. 5); and is further configured to: at a first time, identify a first temporal pattern of force fluctuations in the first series of force data, the first temporal pattern comprising a set of force peaks within a force activation range and occurring within an activation time interval; in response to detecting the first temporal pattern:-activate the transmitter; and trigger transmission of the first series of force data and the second series of orientation data, via the transmitter, to the controller; at a second time, identify a second temporal pattern of force fluctuations in the first series of force data, the second pattern different from the first temporal pattern; and o in response to detecting the second temporal pattern, cease transmission of the first series of force data and the second series of orientation data to the controller (the structure of Singh comprises a transmitter in the femoral head which is fully capable of performing this intended use since the transmitter in the femoral head communicates with a receiver 317; par. 0038 discloses the force data is transferred to the processing system 300; par. 0044 discloses the processing system 300 analyzes the data in real-time; par. 0049 discloses the data CPU 311 performs data analysis and identify trends and compares force data); the instrumented femoral head 216: further comprises a transmitter par. 0056 discloses microprocessors 231 and 411 provide wireless communications; Fig. 5) and a receiver 317; and is further configured to: at a first time, receive an activation signal from the controller via the receiver; in response to receiving the activation signal, trigger transmission of the first series of force data and the second series of orientation data to the controller via the transmitter; at a second time, receive a deactivation signal from the controller via the receiver; and in response to receiving the deactivation signal, cease transmission of the first series of force data and the second series of orientation data (the structure of Singh comprises a transmitter and a receiver which is fully capable of performing this intended use).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Hunter to include the instrumented femoral head: further comprises a transmitter; and is further configured to: at a first time, identify a first temporal pattern of force fluctuations in the first series of force data, the first temporal pattern comprising a set of force peaks within a force activation range and occurring within an activation time interval; in response to detecting the first temporal pattern:- activate the transmitter; and- trigger transmission of the first series of force data and the second series of orientation data, via the transmitter, to the controller; at a second time, identify a second temporal pattern of force fluctuations in the first series of force data, the second pattern different from the first temporal pattern; and o in response to detecting the second temporal pattern, cease transmission of the first series of force data and the second series of orientation data to the controller; the instrumented femoral head: further comprises a transmitter and a receiver; and is further configured to: at a first time, receive an activation signal from the controller via the receiver; in response to receiving the activation signal, trigger transmission of the first series of force data and the second series of orientation data to the controller via the transmitter; at a second time, receive a deactivation signal from the controller via the receiver; and in response to receiving the deactivation signal, cease transmission of the first series of force data and the second series of orientation data, as taught and suggested by Singh, for allowing the surgeons the ability to evaluate orthopedic performance by measuring kinematic and kinetic parameters simultaneously (par. 0006 of Singh).
Regarding claims 14-15, Hunter discloses the claimed system of claim 1; except for wherein the controller is configured to: access the first sequence of orientations of the instrumented femoral head, each orientation in the first sequence orientations comprising: a first vector component indicating orientation of the instrumented femoral head parallel to a gravitational force; a second vector component indicating orientation of the instrumented femoral head orthogonal to the first vector component; and a third vector component indicating orientation of the instrumented femoral head orthogonal to the first vector component and the second vector component; identify a first subset of orientations, in the first sequence of orientations, comprising second vector components within a narrow value range and first vector components and third vector components spanning a wide value range; isolate a first subset of forces in the first series of force data corresponding to the first subset of orientations; associate the first subset of orientations with the first range of motion for internal rotation and external rotation of the hip; and generate the first force versus angular orientation curve comprising a force versus internal rotation angle and external rotation angle curve based on the first subset of forces and the first subset of orientations; wherein the controller is further configured to: identify a second subset of orientations, in the first sequence of orientations, comprising first vector components within the narrow value range and second vector components and third vector components spanning the wide value range; identify a second subset of force data in the first series of force data corresponding to the second subset of orientations; isolate a second subset of forces in the first series of force data corresponding to the second subset of orientations; associate the second subset of orientations with a second range of motion for abduction and adduction of the hip; and generate a force versus abduction and adduction curve based on the second subset of forces and the second subset of orientations.
However, Singh teaches a similar system comprising wherein the controller 310 is configured to: access the first sequence of orientations of the instrumented femoral head, each orientation in the first sequence orientations comprising: a first vector component indicating orientation of the instrumented femoral head parallel to a gravitational force; a second vector component indicating orientation of the instrumented femoral head orthogonal to the first vector component; and a third vector component indicating orientation of the instrumented femoral head orthogonal to the first vector component and the second vector component; identify a first subset of orientations, in the first sequence of orientations, comprising second vector components within a narrow value range and first vector components and third vector components spanning a wide value range; isolate a first subset of forces in the first series of force data corresponding to the first subset of orientations; associate the first subset of orientations with the first range of motion for internal rotation and external rotation of the hip; and generate the first force versus angular orientation curve comprising a force versus internal rotation angle and external rotation angle curve based on the first subset of forces and the first subset of orientations; wherein the controller is further configured to: identify a second subset of orientations, in the first sequence of orientations, comprising first vector components within the narrow value range and second vector components and third vector components spanning the wide value range; identify a second subset of force data in the first series of force data corresponding to the second subset of orientations; isolate a second subset of forces in the first series of force data corresponding to the second subset of orientations; associate the second subset of orientations with a second range of motion for abduction and adduction of the hip; and generate a force versus abduction and adduction curve based on the second subset of forces and the second subset of orientations (the structure of the controller 310 and the sensing units 230 and 221 are fully capable of performing this intended use; par. 0035 discloses analyzing force data including abduction/adduction angle).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Hunter to include wherein the controller is configured to: access the first sequence of orientations of the instrumented femoral head, each orientation in the first sequence orientations comprising: a first vector component indicating orientation of the instrumented femoral head parallel to a gravitational force; a second vector component indicating orientation of the instrumented femoral head orthogonal to the first vector component; and a third vector component indicating orientation of the instrumented femoral head orthogonal to the first vector component and the second vector component; identify a first subset of orientations, in the first sequence of orientations, comprising second vector components within a narrow value range and first vector components and third vector components spanning a wide value range; isolate a first subset of forces in the first series of force data corresponding to the first subset of orientations; associate the first subset of orientations with the first range of motion for internal rotation and external rotation of the hip; and generate the first force versus angular orientation curve comprising a force versus internal rotation angle and external rotation angle curve based on the first subset of forces and the first subset of orientations; wherein the controller is further configured to: identify a second subset of orientations, in the first sequence of orientations, comprising first vector components within the narrow value range and second vector components and third vector components spanning the wide value range; identify a second subset of force data in the first series of force data corresponding to the second subset of orientations; isolate a second subset of forces in the first series of force data corresponding to the second subset of orientations; associate the second subset of orientations with a second range of motion for abduction and adduction of the hip; and generate a force versus abduction and adduction curve based on the second subset of forces and the second subset of orientations, as taught and suggested by Singh, for allowing the surgeons the ability to evaluate orthopedic performance by measuring kinematic and kinetic parameters simultaneously (par. 0006 of Singh).
Claims 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (2016/0029952) in view of Singh et al. (2015/0297362) “Singh” further in view of de la Barrera (2006/0095047).
Hunter in view of Singh discloses the claimed system of claim 1; except for the controller is coupled to a display and is further configured to: detect a global minimum force of the first force versus angular orientation curve; and in response to the global minimum force exceeding a minimum force threshold: detect impingement of the instrumented femoral head and the acetabulum resulting from a current length of the neck of the femoral stem component exceeding a target length; predict the target length of the neck of the femoral stem component, the target length less than the current length of the neck of the femoral stem component, based on a difference between the global minimum force and the minimum force threshold; generate a recommendation to shorten the current length of the neck of the femoral stem component according to the target length; and o transmit the recommendation to the display for presentation to a surgeon; wherein the controller is further configured to: detect a global minimum force of the first force versus angular orientation curve; and in response to the global minimum force falling below a minimum force threshold: detect subluxation of the femoral stem component in the acetabulum of the pelvis; generate a recommendation to increase a length of the neck of the femoral stem component; and render the recommendation on a display arranged proximal the patient; wherein the controller is further configured to: define the first range of motion of the femur comprising a set of angular orientations accessible to the femur, each angular orientation in the set of angular orientations associated with a force less than a maximum threshold force; identify a first characteristic of the first force versus angular orientation curve, the first characteristic comprising a discontinuity in the force versus angular orientation curve, the discontinuity occurring within the first range of motion of the femur ;identify a second characteristic of the first force versus angular orientation curve, the second characteristic comprising a maximum force at the discontinuity, the maximum force at the discontinuity falling below the maximum threshold force; match the first characteristic and the second characteristic to a template curve characteristic stored in a library and associated with a dislocation event; and in response to matching the first characteristic and the second characteristic to the template curve characteristic: predict dislocation of the femoral stem component from the acetabulum; o generate a notification indicating predicted dislocation of the femoral stem component from the acetabulum; and o render the notification on a display proximal the patient; wherein the controller is further configured to: define the first range of motion of the femur comprising a set of angular orientations accessible to the femur, each angular orientation in the set of angular orientations associated with a force below a maximum threshold force; identify a first characteristic of the first force versus angular orientation curve, the first characteristic comprising a peak in the force versus angular orientation curve; identify a second characteristic of the first force versus angular orientation curve, the second characteristic comprising a maximum force associated with the peak, the maximum force falling below the maximum threshold force; match the first characteristic and the second characteristic to template curve characteristic stored in a library and associated with soft tissue impingement; and in response to matching the first characteristic and the second characteristic to the template curve characteristic: predict soft tissue impingement by the femoral stem component; generate a notification indicating predicted soft tissue impingement; and render the notification on a display proximal the patient; the controller is further configured to: detect a first characteristic of the first force versus angular orientation curve, the first characteristic comprising an asymmetric profile of the first force versus angular orientation curve across the first range of motion; detect impingement of the instrumented femoral head on the acetabulum based on the asymmetric profile of the first force versus angular orientation curve; associate impingement of the instrumented femoral head on the acetabulum with an angle of the neck of the femoral stem component differing from a target angle of the femoral stem component; calculate the target angle of the neck of the femoral stem component predicted to reduce asymmetry of the first force versus angular orientation curve; generate a recommendation to adjust the angle of the neck of the femoral stem component to the target angle; and render the recommendation on a display arranged proximal the patient; the controller is further configured to: access a target force versus angular orientation curve; calculate a similarity score for the first force versus angular orientation curve and the target force versus angular orientation curve; and based on the similarity score exceeding a threshold similarity score: generate a notification confirming an angle of the neck of the femoral stem component and a length of the femoral stem component; and serve the notification to a display arranged proximal the patient.
However, de la Barrera teaches a similar system comprising force sensors (par. 0033) in communication with a controller 102 (par. 0026) that is coupled to a display 104 (Fig. 1) and is further configured to: detect a global minimum force of the first force versus angular orientation curve; and in response to the global minimum force exceeding a minimum force threshold: detect impingement of the instrumented femoral head and the acetabulum resulting from a current length of the neck of the femoral stem component exceeding a target length; predict the target length of the neck of the femoral stem component, the target length less than the current length of the neck of the femoral stem component, based on a difference between the global minimum force and the minimum force threshold; generate a recommendation to shorten the current length of the neck of the femoral stem component according to the target length; and o transmit the recommendation to the display for presentation to a surgeon; wherein the controller is further configured to: detect a global minimum force of the first force versus angular orientation curve; and in response to the global minimum force falling below a minimum force threshold: detect subluxation of the femoral stem component in the acetabulum of the pelvis; generate a recommendation to increase a length of the neck of the femoral stem component; and render the recommendation on a display arranged proximal the patient; wherein the controller is further configured to: define the first range of motion of the femur comprising a set of angular orientations accessible to the femur, each angular orientation in the set of angular orientations associated with a force less than a maximum threshold force; identify a first characteristic of the first force versus angular orientation curve, the first characteristic comprising a discontinuity in the force versus angular orientation curve, the discontinuity occurring within the first range of motion of the femur ;identify a second characteristic of the first force versus angular orientation curve, the second characteristic comprising a maximum force at the discontinuity, the maximum force at the discontinuity falling below the maximum threshold force; match the first characteristic and the second characteristic to a template curve characteristic stored in a library and associated with a dislocation event; and in response to matching the first characteristic and the second characteristic to the template curve characteristic: predict dislocation of the femoral stem component from the acetabulum; generate a notification indicating predicted dislocation of the femoral stem component from the acetabulum; and o render the notification on a display proximal the patient; wherein the controller is further configured to: define the first range of motion of the femur comprising a set of angular orientations accessible to the femur, each angular orientation in the set of angular orientations associated with a force below a maximum threshold force; identify a first characteristic of the first force versus angular orientation curve, the first characteristic comprising a peak in the force versus angular orientation curve; identify a second characteristic of the first force versus angular orientation curve, the second characteristic comprising a maximum force associated with the peak, the maximum force falling below the maximum threshold force; match the first characteristic and the second characteristic to template curve characteristic stored in a library and associated with soft tissue impingement; and in response to matching the first characteristic and the second characteristic to the template curve characteristic: predict soft tissue impingement by the femoral stem component; generate a notification indicating predicted soft tissue impingement; and render the notification on a display proximal the patient; the controller is further configured to: detect a first characteristic of the first force versus angular orientation curve, the first characteristic comprising an asymmetric profile of the first force versus angular orientation curve across the first range of motion; detect impingement of the instrumented femoral head on the acetabulum based on the asymmetric profile of the first force versus angular orientation curve; associate impingement of the instrumented femoral head on the acetabulum with an angle of the neck of the femoral stem component differing from a target angle of the femoral stem component; calculate the target angle of the neck of the femoral stem component predicted to reduce asymmetry of the first force versus angular orientation curve; generate a recommendation to adjust the angle of the neck of the femoral stem component to the target angle; and render the recommendation on a display arranged proximal the patient; the controller is further configured to: access a target force versus angular orientation curve; calculate a similarity score for the first force versus angular orientation curve and the target force versus angular orientation curve; and based on the similarity score exceeding a threshold similarity score: generate a notification confirming an angle of the neck of the femoral stem component and a length of the femoral stem component; and serve the notification to a display arranged proximal the patient (the structure of the controller and the display are capable of performing this intended use; abstract and pars. 0034 and 0038 disclose the system 100 collects force data allowing for fine-tuning of the femoral implant including neck length adjustment based on the acquired force data indicating joint impingement/dislocation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Hunter to include the controller is coupled to a display and is further configured to: detect a global minimum force of the first force versus angular orientation curve; and in response to the global minimum force exceeding a minimum force threshold: detect impingement of the instrumented femoral head and the acetabulum resulting from a current length of the neck of the femoral stem component exceeding a target length; predict the target length of the neck of the femoral stem component, the target length less than the current length of the neck of the femoral stem component, based on a difference between the global minimum force and the minimum force threshold; generate a recommendation to shorten the current length of the neck of the femoral stem component according to the target length; and o transmit the recommendation to the display for presentation to a surgeon; wherein the controller is further configured to: detect a global minimum force of the first force versus angular orientation curve; and in response to the global minimum force falling below a minimum force threshold: detect subluxation of the femoral stem component in the acetabulum of the pelvis; generate a recommendation to increase a length of the neck of the femoral stem component; and render the recommendation on a display arranged proximal the patient; wherein the controller is further configured to: define the first range of motion of the femur comprising a set of angular orientations accessible to the femur, each angular orientation in the set of angular orientations associated with a force less than a maximum threshold force; identify a first characteristic of the first force versus angular orientation curve, the first characteristic comprising a discontinuity in the force versus angular orientation curve, the discontinuity occurring within the first range of motion of the femur ;identify a second characteristic of the first force versus angular orientation curve, the second characteristic comprising a maximum force at the discontinuity, the maximum force at the discontinuity falling below the maximum threshold force; match the first characteristic and the second characteristic to a template curve characteristic stored in a library and associated with a dislocation event; and in response to matching the first characteristic and the second characteristic to the template curve characteristic: predict dislocation of the femoral stem component from the acetabulum; o generate a notification indicating predicted dislocation of the femoral stem component from the acetabulum; and o render the notification on a display proximal the patient; wherein the controller is further configured to: define the first range of motion of the femur comprising a set of angular orientations accessible to the femur, each angular orientation in the set of angular orientations associated with a force below a maximum threshold force; identify a first characteristic of the first force versus angular orientation curve, the first characteristic comprising a peak in the force versus angular orientation curve; identify a second characteristic of the first force versus angular orientation curve, the second characteristic comprising a maximum force associated with the peak, the maximum force falling below the maximum threshold force; match the first characteristic and the second characteristic to template curve characteristic stored in a library and associated with soft tissue impingement; and in response to matching the first characteristic and the second characteristic to the template curve characteristic: predict soft tissue impingement by the femoral stem component; generate a notification indicating predicted soft tissue impingement; and render the notification on a display proximal the patient; the controller is further configured to: detect a first characteristic of the first force versus angular orientation curve, the first characteristic comprising an asymmetric profile of the first force versus angular orientation curve across the first range of motion; detect impingement of the instrumented femoral head on the acetabulum based on the asymmetric profile of the first force versus angular orientation curve; associate impingement of the instrumented femoral head on the acetabulum with an angle of the neck of the femoral stem component differing from a target angle of the femoral stem component; calculate the target angle of the neck of the femoral stem component predicted to reduce asymmetry of the first force versus angular orientation curve; generate a recommendation to adjust the angle of the neck of the femoral stem component to the target angle; and render the recommendation on a display arranged proximal the patient; the controller is further configured to: access a target force versus angular orientation curve; calculate a similarity score for the first force versus angular orientation curve and the target force versus angular orientation curve; and based on the similarity score exceeding a threshold similarity score: generate a notification confirming an angle of the neck of the femoral stem component and a length of the femoral stem component; and serve the notification to a display arranged proximal the patient, as taught and suggested by de la Barrera, for providing a surgical system that minimizes impingement/dislocation by allowing femoral neck length adjustability (par. 0015 and 0038 of de la Barrera).
Conclusion
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774