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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 63/344,086 filed 05/20/2022.
Status of Claims
This Office Action is responsive to the claims filed on 01/05/2026. Claims 1 and 18 have been amended. Claims 13-17 have been canceled. Claims 1-12 and 18 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, 5-7, 11, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wilde (US 20210353431 A1) in view of Hladio-292 (US 20150182292 A1).
Regarding claim 1, Wilde teaches a method (Paragraph [0091]; method of implant placement) for measuring the position of a broach tool (Paragraph [0014]; calculate a real-time position and orientation of the positioning system, whereby, due to the fixed spatial relationship between the positioning system and the implant component, via the coupler) in a total hip arthroplasty procedure (Paragraph [0087]; present invention can also be applied to implant placement in primary hip replacement surgical procedures) comprising:
attaching a first tracking array (Paragraph [0085]; transmitter 85 (accelerometer/gyroscope, visual array for line of sight tracking, etc.), Fig. 1; Transmitter 85 includes a visual array for line of sight tracking) to the femur of a patient (Paragraph [0080]; This is performed by placing bone reference markers 90 in the bones; Bone reference markers 90 may be localized by centralized computing system 45 virtually via probe 95 or by transmitter 85; Paragraph [0084]; Reference markers 90 would be placed in the femur and tibia bones and registered; Fig. 1);
registering the position of the femur using the tracking array (Paragraph [0080]; Bone reference markers 90 may be localized by centralized computing system 45 virtually via probe 95 or by transmitter 85… After the bone reference markers 90 are registered and data collected on the original femoral stem 5 and processed by centralized computing system 45);
attaching a second tracking array (Paragraph [0064]; coupler 10 is configured to mount to an implant component; Paragraph [0066]-[0067]; positioning system 15 is integrally formed as part of coupler 10, i.e., positioning system 15 and coupler 10 are a single, unitary component… positioning system 15 includes an array of visual/line-of-sight sensors (e.g., infrared arrays, etc.) configured to determine the real-time position of femoral stem 5) to a broach tool (Paragraph [0081]; coupler 10 and positioning system 15 can be attached to the new femoral stem (or trial stem/broach)) after broaching the femoral canal (Paragraph [0084]; robotic arm 50 could also be used (based on the above data) to prepare the canal for a broach and/or stem attachment(s); Paragraph [0088]; Coupler 10 and positioning system 15 construct may also connect to a broach or trial implant (not shown) to provide the same real-time information on seating of the broach; Fig. 7 shows the step of Broach Femur and afterward the step of Attach coupler to trial neck on broach); and
determining the position of the broach tool with respect to the femur (Paragraph [0080]; This is performed by placing bone reference markers 90 in the bones prior to affixing coupler 10 and positioning system 15 to femoral stem 5 for use in extraction of femoral stem 5. Bone reference markers 90 are used to reference the position of original femoral stem 5 (before extraction) in relation to the bones (e.g., femur and acetabulum/pelvis)) based on a comparison between position of the first and second tracking arrays (Paragraph [0080]; The initial hip mechanics/parameters would be determined prior to implant extraction based on reference markers 90/coupler 10 relationship; transmitter 85 (accelerometer/gyroscope, visual array for line of sight tracking, etc.) is attached to bone reference marker 90 to provide real-time positioning data of the bones to centralized computing system 45. This allows for triangulation with positioning system 15 and coupler 10 to provide real-time positioning and orientation data of femoral stem 5 in relation to the bones.).
Wilde does not teach registering the position of the femur without use of bone pins; and
determining the position of the broach tool without use of bone pins.
Hladio-292, however, teaches registering the position of the femur without use of bone pins (Paragraph [0051]; A patient specific femur jig 206 is shown mated with a femur 202 in a unique positional relationship. In this case, the PSJ 206 is affixed to the bone during the guided portion of the surgery, and may be coupled in a unique positional relationship with a beacon 208; Paragraph [0052]; Where the PSJ's are used to guide the coupling of the sensor or beacon to a bone, that bone is inherently registered to the sensor or beacon; Paragraph [0055]; FIG. 5 is an illustration of a patient-specific femoral (PSF) jig 500; Fig. 5 shows a jig for coupling to the tracking marker without the use of bone pins; Fig. 7); and
determining the position of the broach tool without use of bone pins (Paragraph [0051]; A trackable surgical tool 218 (i.e. an instrument with an other optically trackable beacon rigidly affixed in a known pose) is depicted… to those skilled in the art that other surgical instruments may be equivalently used, e.g. broaches; Paragraph [0064]; In step 1114, during broaching and prosthesis implantation, the positional relationship between broach/prosthesis and femur sensor unit is tracked and information (e.g., femoral version) is provided to the surgeon).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Wilde to have registered the position of the femur without use of bone pins; and determined the position of the broach tool without use of bone pins as taught by Hladio-292 because it would have been a known method of providing a mechanical connector for attachment of a tracking sensor that further would have allowed providing a determinable relative positioning with respect to any system by using a registration tools to match the femoral contour and identifies the femoral anatomy, and further provide a guide to cut the femoral head (Paragraph [0055]).
Regarding claim 5, together Wilde and Hladio-292 teach all of the limitations of claim 1 as noted above.
Wilde further teaches registering the position of the femur includes tracking the first tracking array using a tracking system having one or more sensors to collect real-time position data (Paragraph [0067]; Positioning system 15 includes one or more sensors; Paragraph [0071]; determined by positioning system 15 and tracked by centralized computing system 45; Paragraph [0080]; In an embodiment, transmitter 85 (accelerometer/gyroscope, visual array for line of sight tracking, etc.) is attached to bone reference marker 90 to provide real-time positioning data of the bones to centralized computing system 45); and
software (Paragraph [0032]; The computerized joint software/templating system) running on a surgical computer calculates and registers the position of the femur based on the position data (Paragraph [0069]; . Computing system 45 receives and processes data received from positioning system 15; Paragraph [0064]; (established when registering positioning system 15 with centralized computing system 45 preoperatively or intraoperatively), and the fixed spatial relationship between positioning system 15 and the implant component, via coupler 10, centralized computing system 45 is able to determine the real-time position and orientation of the implant component in 3-dimensional space).
Regarding claim 6, together Wilde and Hladio-292 teach all of the limitations of claim 1 as noted above.
Wilde further teaches attaching the second tracking array to the broach tool comprises:
providing a broach adapter attached to the broach tool (Paragraph [0064]; coupler 10 is configured to mount to an implant component; Paragraph [0081]; coupler 10 and positioning system 15 can be attached to the new femoral stem (or trial stem/broach)) and attaching the second tracking array to the broach adapter (Paragraph [0066]; Alternatively, positioning system 15 and coupler 10 are separate components, whereby positioning system 15 is removably coupled to coupler 10. When coupled, positioning system 15 and coupler 10 are configured to maintain a fixed orientation relative to one another until decoupled).
Regarding claim 7, together Wilde and Hladio-292 teach all of the limitations of claim 6 as noted above.
Wilde further teaches the broach adapter is adapted to fit the geometry of the broach tool (Paragraph [0066]; coupler 10 may be coupled to the implant component by the surgeon or staff at the time of surgery; Paragraph [0068]; coupler 10 engages trunnion 20, positioning system 15 moves in synchrony with femoral stem; Fig. 1 shows the coupler is adapted to fit the geometry of the tool.).
Regarding claim 11, together Wilde and Hladio-292 teach all of the limitations of claim 1 as noted above.
Wilde further teaches comparing the position of the first and second tracking arrays comprises:
using a tracking system having one or more sensors (Paragraph [0067]; Positioning system 15 includes one or more sensors; Paragraph [0071]; determined by positioning system 15 and tracked by centralized computing system 45.) to collect real-time position data of the first and second tracking arrays (Paragraph [0080]; The initial hip mechanics/parameters would be determined prior to implant extraction based on reference markers 90/coupler 10 relationship; transmitter 85 (accelerometer/gyroscope, visual array for line of sight tracking, etc.) is attached to bone reference marker 90 to provide real-time positioning data of the bones to centralized computing system 45. This allows for triangulation with positioning system 15 and coupler 10 to provide real-time positioning and orientation data of femoral stem 5 in relation to the bones.); and
calculating the position of the broach tool relative to the registered position of the femur based on the position data (Paragraph [0080]; This is performed by placing bone reference markers 90 in the bones prior to affixing coupler 10 and positioning system 15 to femoral stem 5 for use in extraction of femoral stem 5. Bone reference markers 90 are used to reference the position of original femoral stem 5 (before extraction) in relation to the bones (e.g., femur and acetabulum/pelvis); Claim 1; wherein the centralized computing system is configured to calculate a real-time position and orientation of the implant component, based on the real-time position and orientation of the positioning system, wherein the centralized computing system is configured to synthesize data from the joint templating software program).
Regarding claim 12, together Wilde and Hladio-292 teach all of the limitations of claim 1 as noted above.
Wilde further teaches calculating the position of the broach tool is performed by software (Paragraph [0032]; The computerized joint software/templating system) running on a surgical computer (Paragraph [0064]; established when registering positioning system 15 with centralized computing system 45 preoperatively or intraoperatively).
Regarding claim 18, Wilde teaches a system (Paragraph [0014]; the system for extracting and placing joint implants) comprising:
a tracking system having one or more sensors (Paragraph [0067]; Positioning system 15 includes one or more sensors; Paragraph [0071]; determined by positioning system 15 and tracked by centralized computing system 45.);
a processor (Paragraph [0069]; . Computing system 45 receives and processes data received from positioning system 15); and
software for execution on the processor (Paragraph [0032]; The computerized joint software/templating system), the software causing the system (Paragraph [0091]; summarizes the method of implant placement in primary hip replacement surgical procedures using the present system) to:
determine a position of a femur by tracking a first tracking array mechanically connected to the femur using the tracking system to collect real-time position data of the first tracking array (Paragraph [0080]; In an embodiment, transmitter 85 (accelerometer/gyroscope, visual array for line of sight tracking, etc.) is attached to bone reference marker 90 to provide real-time positioning data of the bones to centralized computing system 45; Paragraph [0084]; Reference markers 90 would be placed in the femur and tibia bones and registered; Fig. 1); and
determine the position of a broach tool (Paragraph [0081]; coupler 10 and positioning system 15 can be attached to the new femoral stem (or trial stem/broach); Paragraph [0088]; Coupler 10 and positioning system 15 construct may also connect to a broach or trial implant (not shown) to provide the same real-time information on seating of the broach) disposed in the femoral canal of the femur (Paragraph [0084]; robotic arm 50 could also be used (based on the above data) to prepare the canal for a broach and/or stem attachment(s); Paragraph [0088]; Coupler 10 and positioning system 15 construct may also connect to a broach or trial implant (not shown) to provide the same real-time information on seating of the broach; Fig. 7 shows the step of Broach Femur and afterward the step of Attach coupler to trial neck on broach) by tracking a second tracking array mechanically connected to the broach tool using the tracking system (Paragraph [0064]; coupler 10 is configured to mount to an implant component; Paragraph [0066]-[0067]; positioning system 15 is integrally formed as part of coupler 10, i.e., positioning system 15 and coupler 10 are a single, unitary component… positioning system 15 includes an array of visual/line-of-sight sensors (e.g., infrared arrays, etc.) configured to determine the real-time position of femoral stem 5) to collect real-time position data of the second tracking array (Paragraph [0088]; Coupler 10 and positioning system 15 construct may also connect to a broach or trial implant (not shown) to provide the same real-time information on seating of the broach or trial implant prior to placement of final implant femoral stem 5);
wherein the software calculates the position of the broach tool with respect to the femur (Paragraph [0080]; This is performed by placing bone reference markers 90 in the bones prior to affixing coupler 10 and positioning system 15 to femoral stem 5 for use in extraction of femoral stem 5. Bone reference markers 90 are used to reference the position of original femoral stem 5 (before extraction) in relation to the bones (e.g., femur and acetabulum/pelvis); Claim 1; wherein the centralized computing system is configured to calculate a real-time position and orientation of the implant component, based on the real-time position and orientation of the positioning system, wherein the centralized computing system is configured to synthesize data from the joint templating software program) based on a comparison of the position data representing the position of the first and second tracking arrays (Paragraph [0080]; The initial hip mechanics/parameters would be determined prior to implant extraction based on reference markers 90/coupler 10 relationship; transmitter 85 (accelerometer/gyroscope, visual array for line of sight tracking, etc.) is attached to bone reference marker 90 to provide real-time positioning data of the bones to centralized computing system 45. This allows for triangulation with positioning system 15 and coupler 10 to provide real-time positioning and orientation data of femoral stem 5 in relation to the bones.).
Wilde does not teach determining the position of the femur without use of bone pins; and
determining the position of the broach tool without use of bone pins.
Hladio-292, however, teaches determining the position of the femur without use of bone pins (Paragraph [0051]; A patient specific femur jig 206 is shown mated with a femur 202 in a unique positional relationship. In this case, the PSJ 206 is affixed to the bone during the guided portion of the surgery, and may be coupled in a unique positional relationship with a beacon 208; Paragraph [0052]; Where the PSJ's are used to guide the coupling of the sensor or beacon to a bone, that bone is inherently registered to the sensor or beacon; Paragraph [0055]; FIG. 5 is an illustration of a patient-specific femoral (PSF) jig 500; Fig. 5 shows a jig for coupling to the tracking marker without the use of bone pins; Fig. 7); and
determining the position of the broach tool without use of bone pins (Paragraph [0051]; A trackable surgical tool 218 (i.e. an instrument with an other optically trackable beacon rigidly affixed in a known pose) is depicted… to those skilled in the art that other surgical instruments may be equivalently used, e.g. broaches; Paragraph [0064]; In step 1114, during broaching and prosthesis implantation, the positional relationship between broach/prosthesis and femur sensor unit is tracked and information (e.g., femoral version) is provided to the surgeon).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Wilde to have registered the position of the femur without use of bone pins; and determined the position of the broach tool without use of bone pins as taught by Hladio-292 because it would have been a known method of providing a mechanical connector for attachment of a tracking sensor that further would have allowed providing a determinable relative positioning with respect to any system by using a registration tools to match the femoral contour and identifies the femoral anatomy, and further provide a guide to cut the femoral head (Paragraph [0055]).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Wilde in view of Hladio-292 as applied to claim 1 above, and further in view of Hladio-783 (US 20160113783 A1).
Regarding claim 2, together Wilde and Hladio-292 teach all of the limitations of claim 1 as noted above.
Wilde does not explicitly teach the first tracking array is attached to the femur via a mounting plate that magnetically engages with a mating plate on a holder for the first tracking array.
Hladio-783, however, teaches a first tracking array is attached to the femur (Paragraph [0036]; there is a target 210 coupled to the femur 212 via a beacon 214, Fig. 2) via a mounting plate (Paragraph [0036]; a femur platform 216, Fig. 2; Paragraph [0071]; first side 1100, Figs. 11A and 11B) that magnetically engages (Paragraph [0071]-[0072]; complementary magnets 1108 (on the first side 1100) and 1110 (on the second side 1102) are used to generate a coupling force; Paragraph [0072]; A beacon 214 with a mating quick connect mechanism is intended to interface with the femur platform quick connection 1008 while rigidly holding the target 210) with a mating plate (Paragraph [0071]; second side 1102, Fig. 11A and 11B) on a holder for the first tracking array (Paragraph [0036]; beacon 214, Fig. 2; Paragraph [0042]; beacon 214 (coupled with the target 210)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the first tracking array of Wilde in view of Hladio-292 to have been attached to the femur via a mounting plate that magnetically engages with a mating plate on a holder for the first tracking array as taught by Hladio-783 because it would have been a well-known and understood method of mounting a tracking array to a femur and further would have allowed the target to easily “snap” into place which would been very important to surgeon-users, who value simplicity of use and confidence via positive tactile/audible feedback during use of the tracking system (Hladio-783, Paragraph [0071]).
Regarding claim 3, together Wilde, Hladio-292, and Hladio-783 teach all of the limitations of claim 2 as noted above.
Wilde does not explicitly teach the mounting plate allows for multiple orientations of the first tracking array.
Hladio-783, however, further teaches the mounting plate allows for multiple orientations of the first tracking array (Paragraph [0071]; Note that the two halves may be positioned in only two orientations, 180 degrees from each other; Figs. 11A and 11B show the two mounting plates can be oriented in two directions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the mounting plate of Wilde in view of Hladio-292 and Hladio-783 such that the mounting plate allows for multiple orientations of the first tracking array as further taught by Hladio-783 because it would have provided flexibility of the mounting system for use in multiple positions (Hladio-783, Paragraph [0071]).
Regarding claim 4, together Wilde, Hladio-292, and Hladio-783 teach all of the limitations of claim 2 as noted above.
Wilde does not explicitly teach the mounting plate is attached to the proximal femur targeting the greater trochanter.
Hladio-783, however, further teaches the mounting plate is attached to the proximal femur targeting the greater trochanter (Paragraph [0068]; The femur platform body 1002 is impacted into the femur (preferably the greater trochanter), Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the mounting plate of Wilde in view of Hladio-292 and Hladio-783 to have been attached to the proximal femur targeting the greater trochanter as further taught by Hladio-783 because it would have been a well-known and understood position for mounting the tracking device while further being in a position that would not interfere with the broaching process and further be in a place that provides clear, un-crowded view of the surgical site (Hladio-783, Paragraphs [0068]-[0069]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wilde in view of Hladio-292 as applied to claim 6 above, and further in view of Chaney (US 20140276850 A1).
Regarding claim 8, together Wilde and Hladio-292 teach all of the limitations of claim 6 as noted above.
Wilde does not explicitly teach the broach adapter attaches to the broach tool using a spring mechanism.
Chaney, however, teaches a broach adapter attaches to the broach tool (Paragraph [0039]-[0040]; attachment mechanism 50…; position to a clamped position, the clamp lever 82 engages the flange 44 of the broach 20 to secure the intramedullary surgical instrument 12 to the instrument handle 14 as described below; Figs. 1 and 2) using a spring mechanism (Paragraph [0040]; the attachment mechanism 50 of the instrument handle 14 further includes a leaf spring 84 that is coupled between the release lever 80 and the clamp lever 82; Paragraph [0063]; move the release lever 80 to the clamped position, and the catch 130 engages the flange 44, thereby securing the broach 20 to the instrument handle 14. When the release lever 80 is in the clamped position, the leaf spring 84 provides clamping force to secure the intramedullary surgical instrument 12 to the instrument handle 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the broach adapter of Wilde in view of Hladio-292 to have attached to the broach tool using a spring mechanism as taught by Chaney as it would have been a well known mechanism for attaching an instrument to a broach that further would have provided a secure attachment in a fixed position (Chaney, Paragraph [0063]).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Wilde in view of Hladio-292 as applied to claim 6 above, and further in view of Murray (US 20200360091 A1).
Regarding claim 9, together Wilde and Hladio-292 teach all of the limitations of claim 6 as noted above.
Wilde does not explicitly teach the broach adapter includes a slot adapted to accept a proximal end of a tracking array holder.
Murray, however, teaches an adaptor (Paragraph [0028]; attachment assembly 700, Fig.17 ) including a slot (Paragraph [0081]; fixation body 732 can define an aperture 745 that extends from the proximal end 740 to the fixation body recess 734, Fig. 19 and 20) adapted to accept a proximal end (Paragraph [0067]; The arm 402, Figs. 18-20) of a tracking array holder (Paragraph [0076]; the attachment assembly 700 includes an arm 402 that is configured to support the patient reference array 100, Fig. 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the broach adapter of Wilde in view of Hladio-292 to have included a slot adapted to accept a proximal end of a tracking array holder as taught by Murray because it would have been a known method of mounting a tracking array to surgical instrument so as to avoid movement of the patient reference array relative to the patient anatomy during a surgical procedure (Murray, Paragraph [0027]).
Regarding claim 10, together Wilde, Hladio-292, and Murray teach all of the limitations of claim 9 as noted above.
Wilde does not explicitly teach the proximal end of the tracking array holder includes a spring component having a protrusion thereon which engages a depression defined in the slot of the broaching adapter.
Murray, however, further teaches the proximal end of the tracking array holder includes a spring component (Paragraph [0079]; The coupler 730 can include a biasing element 715, such as a spring, Fig. 19 and 20) having a protrusion thereon (Paragraph [0081]; the shaft 414 can be received through the aperture 745 such that at least a portion of the at least one engagement member 716 is received in the recess 734; Fig. 20 shows a shaft with a protrusion) which engages a depression defined in the slot of the adapter (Paragraph [0079]; at least one engagement member 716 can be configured to move outwardly… and hence the engagement surface 718, can be fixedly attached to the shaft 414 with respect to movement along the central axis K; Paragraph [0081]; The shaft 414 can be received through the aperture 745; Fig. 20 shows a depression in the recess of the adaptor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the proximal end of the tracking array holder of Wilde in view of Hladio-292 and Murray to have further included a spring component having a protrusion thereon which engages a depression defined in the slot of the broaching adapter as taught by Murray because it would have been a known method of engaging a tracking device with to surgical instrument so as to avoid movement of the patient reference array relative to the patient anatomy during a surgical procedure and further cause the at least one engagement surface to apply a locking force to the medical implant, thereby locking a position of the medical device (Paragraph [0078]).
Response to Arguments
Claim Rejections under – 35 U.S.C. § 102 and 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 102 and 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anh Tuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 4/21/26
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