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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/12/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 6, 8-17, 19-22, & 24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-4, 9, 13, 17, 20, & 22 are rejected under 35 U.S.C. 103 as being unpatentable over Barreto (US20180071032A1) in view of Stolka et al (US20150148668A1;hereinafter referred to as Stalko).
Regarding Claim 1, Barreto discloses a method for determining an actual depth of a reamer within a bone (“(iii) the VR environment shows the drilling direction at each frame time instant such that the surgeon can align it for the exit point to be in the Lateral epicondyle (FIG. 5B), (iv) the tunnel is open along the selected trajectory while VTIAC provides the depth from surface at each frame time instant.” [0152], “VTIAC can be applied in assisting the surgeon in several steps of the execution such as indicating the plane of cut to remove humeral head, or guiding the reaming of humeral shaft and/or glenoid.” [0166]), the method comprising:
while the reamer is rotating during drilling of the bone, reading, by a surgical controller through an arthroscope, a portion of a machine-readable pattern on the reamer visible within a surgical site as the reamer translates into the bone (“VTIAC is specially well suited for arthroscopy where the already existing monocular arthroscope acts as the free-moving camera that provides the video input. VTIAC can be successfully employed in any clinical procedure that targets anatomical regions with rigid parts, such as open orthopaedic surgery or dentistry, in which case the operating field must be observed by a camera that can either be attached to a tool or handheld.” [0014], “The small visual markers that are attached to instruments, tools, and anatomy of interest play a fundamental role in VTIAC being key-enablers for using the camera as a measuring device for determining 3D pose.” [0090], “VTIAC shows in a VR environment the registered model and the current orientation of the drilling tool, where this orientation is computed in real-time from the arthroscopic video where both WM and TM can be seen, (iii) the VR environment shows the drilling direction at each frame time instant such that the surgeon can align it for the exit point to be in the Lateral epicondyle (FIG. 5B), (iv) the tunnel is open along the selected trajectory while VTIAC provides the depth from surface at each frame time instant.” [0152]),
determining, by the surgical controller, the actual depth of the reamer within the bone based on the portion of the machine-readable pattern visible during the drilling (“FIG. 6E is an embodiment of using the VTIAC for guiding a perforation or insertion of instrument during PPS. In VR view, the optical axis of the virtual camera is aligned with the desired line of perforation or insertion. The penetration depth displayed is relative to the bone surface at the entry point.” [0042], “VTIAC indicates the location of the footprint by overlaying in video using AR the point in the anatomy where drill tip should be place (the entry point), (ii) VTIAC shows in a VR environment the registered model and the current orientation of the drilling tool, where this orientation is computed in real-time from the arthroscopic video where both WM and TM can be seen, (iii) the VR environment shows the drilling direction at each frame time instant such that the surgeon can align it for the exit point to be in the Lateral epicondyle (FIG. 5B), (iv) the tunnel is open along the selected trajectory while VTIAC provides the depth from surface at each frame time instant.” [0152]);
and displaying, by the surgical controller on a display device, a value indicative of the actual depth of the reamer within the bone (“FIG. 6E is an embodiment of using the VTIAC for guiding a perforation or insertion of instrument during PPS. In VR view, the optical axis of the virtual camera is aligned with the desired line of perforation or insertion. The penetration depth displayed is relative to the bone surface at the entry point.” [0042]).
Barreto does not specifically disclose that the machine-readable pattern comprises a plurality of radial markings spaced apart along a central axis of the reamer, and wherein the radial markings include annular stripes that at least partially circumscribe the reamer.
However, in a similar field of endeavor, Stolka teaches a system for image-guided surgery with a medical tool comprising a shaft and a tip, wherein the shaft of the tool includes an optically detectable feature that allows a position of the tip to be determined [Abstract].
Stolka also teaches that the machine-readable pattern comprises a plurality of radial markings spaced apart along a central axis of the reamer, and wherein the radial markings include annular stripes that at least partially circumscribe the reamer (“tracking patterns may include rings on a medical tool, proprietary pseudo-random binary sequence (PRBS) patterns or a De Bruijn sequence applied onto the medical tool shaft. Imaging system 200 may track the medical tool insertion depth visually, using the discernible part of the pattern to identify the medical tool and determine the section and thus the position of the medical tool tip, either uniquely or up to a finite set of discrete possibilities. The determined depth may be overlaid on medical tool guidance displays (e.g., augmented display 220) with one or multiple medical tool-tip candidate locations. The medical tool guidance display may be configured to display a real-time representation of the medical tool including the position of the tip of the medical tool regardless of whether the tip is obstructed or visible. Due to the nature of the pattern, the visual imaging system may correctly calculates the insertion depth when a portion of the pattern is not viewable by the visual imaging system or when only a portion of a minimum length of the pattern is viewable by an imaging system.” [0034]).
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 Barreto as outlined above with the machine-readable pattern comprises a plurality of radial markings spaced apart along a central axis of the reamer, and wherein the radial markings include annular stripes that at least partially circumscribe the reamer as taught by Stolka, because there remains a need for improved imaging devices for use in image-guided surgery [0005].
Regarding Claim 2, Barreto discloses all limitations noted above except that determining the actual depth of the reamer further comprises: extracting, by the surgical controller, a plurality of depth values from the portion of the machine-readable pattern; and selecting only one of the plurality of depth values to be the actual depth.
However, in a similar field of endeavor, Stolka teaches determining the actual depth of the reamer further comprises: extracting, by the surgical controller, a plurality of depth values from the portion of the machine-readable pattern; and selecting only one of the plurality of depth values to be the actual depth (“tracking patterns may include rings on a medical tool, proprietary pseudo-random binary sequence (PRBS) patterns or a De Bruijn sequence applied onto the medical tool shaft. Imaging system 200 may track the medical tool insertion depth visually, using the discernible part of the pattern to identify the medical tool and determine the section and thus the position of the medical tool tip, either uniquely or up to a finite set of discrete possibilities. The determined depth may be overlaid on medical tool guidance displays (e.g., augmented display 220) with one or multiple medical tool-tip candidate locations. The medical tool guidance display may be configured to display a real-time representation of the medical tool including the position of the tip of the medical tool regardless of whether the tip is obstructed or visible. Due to the nature of the pattern, the visual imaging system may correctly calculates the insertion depth when a portion of the pattern is not viewable by the visual imaging system or when only a portion of a minimum length of the pattern is viewable by an imaging system.” [0034]).
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 Barreto as outlined above with determining the actual depth of the reamer further comprises: extracting, by the surgical controller, a plurality of depth values from the portion of the machine-readable pattern; and selecting only one of the plurality of depth values to be the actual depth as taught by Stolka, because there remains a need for improved imaging devices for use in image-guided surgery [0005].
Regarding Claim 3, Barreto discloses all limitations noted above except that at least one of the annular stripes fully circumscribes the reamer.
However, in a similar field of endeavor, Stolka teaches at least one of the annular stripes fully circumscribes the reamer (“tracking patterns may include rings on a medical tool, proprietary pseudo-random binary sequence (PRBS) patterns or a De Bruijn sequence applied onto the medical tool shaft. Imaging system 200 may track the medical tool insertion depth visually, using the discernible part of the pattern to identify the medical tool and determine the section and thus the position of the medical tool tip, either uniquely or up to a finite set of discrete possibilities. The determined depth may be overlaid on medical tool guidance displays (e.g., augmented display 220) with one or multiple medical tool-tip candidate locations. The medical tool guidance display may be configured to display a real-time representation of the medical tool including the position of the tip of the medical tool regardless of whether the tip is obstructed or visible. Due to the nature of the pattern, the visual imaging system may correctly calculates the insertion depth when a portion of the pattern is not viewable by the visual imaging system or when only a portion of a minimum length of the pattern is viewable by an imaging system.” [0034]).
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 Barreto as outlined above with at least one of the annular stripes fully circumscribes the reamer as taught by Stolka, because there remains a need for improved imaging devices for use in image-guided surgery [0005].
Regarding Claim 4, Barreto discloses reading the portion of the machine- readable pattern further comprises: reading the portion of the machine-readable pattern at a first set of coordinates within a coordinate space; receiving bone geometry information mapped within the coordinate space; and determining, based on comparing the first set of coordinates and the bone geometry information, at least one of the actual depth of the reamer and a trajectory of the reamer (“After accessing the anatomical cavity, the surgeon starts by rigidly attaching a marker to the bone surface that is referred as the World Marker (WM).” [0063], “Consider now an instrument or tool with a similar visual marker attached that is referred as Tool Marker (TM). Repeating the process of the previous paragraph the homography HT can be estimated from image information in order to determine the rigid transformation that maps TM coordinates into camera coordinates. If both WM and TM are simultaneously visible in the image, then it is possible to estimate the 3D poses of world and tool markers in the camera frame and find in a straightforward manner the location T of the tool or instrument in the world coordinate system (FIG. 1B)” [0064], “The orientation for opening the tunnel may be determined by registering a statistical model of the femur bone. For this purpose, the surgeon uses the touch probe to reconstruct the boundary contours of the inter-condyle region (FIG. 4B) or, in alternative, to obtain a sparse 3D reconstruction of the surface of the femur bone (FIG. 4C). This 3D data is fed into a suitable 3D registration algorithm that overlays the statistical model with the patient's anatomy. For opening the tunnel the surgeon uses a drill with a TM such that its position can be related in real time with the 3D data stored in memory that includes reconstruction results and the registered statistical model. One possible strategy for guided opening of the tunnel consists in the following: (i) VTIAC indicates the location of the footprint by overlaying in video using AR the point in the anatomy where drill tip should be place (the entry point), (ii) VTIAC shows in a VR environment the registered model and the current orientation of the drilling tool, where this orientation is computed in real-time from the arthroscopic video where both WM and TM can be seen, (iii) the VR environment shows the drilling direction at each frame time instant such that the surgeon can align it for the exit point to be in the Lateral epicondyle (FIG. 5B), (iv) the tunnel is open along the selected trajectory while VTIAC provides the depth from surface at each frame time instant.” [0152]).
Regarding Claim 9, Barreto discloses all limitations noted above except that at least one of the annular stripes fully circumscribes the reamer.
However, in a similar field of endeavor, Stolka teaches determining the actual depth of the reamer within the bone further comprises using a temporal sequence guide associated with a plurality of markings comprising the machine-readable pattern (“tracking patterns may include rings on a medical tool, proprietary pseudo-random binary sequence (PRBS) patterns or a De Bruijn sequence applied onto the medical tool shaft. Imaging system 200 may track the medical tool insertion depth visually, using the discernible part of the pattern to identify the medical tool and determine the section and thus the position of the medical tool tip, either uniquely or up to a finite set of discrete possibilities. The determined depth may be overlaid on medical tool guidance displays (e.g., augmented display 220) with one or multiple medical tool-tip candidate locations. The medical tool guidance display may be configured to display a real-time representation of the medical tool including the position of the tip of the medical tool regardless of whether the tip is obstructed or visible. Due to the nature of the pattern, the visual imaging system may correctly calculates the insertion depth when a portion of the pattern is not viewable by the visual imaging system or when only a portion of a minimum length of the pattern is viewable by an imaging system.” [0034]).
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 Barreto as outlined above with determining the actual depth of the reamer within the bone further comprises using a temporal sequence guide associated with a plurality of markings comprising the machine-readable pattern as taught by Stolka, because there remains a need for improved imaging devices for use in image-guided surgery [0005].
Regarding Claim 13, Barreto discloses further comprising: determining, by the surgical controller, a diameter of the reamer based on the portion of the machine-readable pattern (“that can be a needle, guide, drill, shaver, saw, burr, or any other object required for proper clinical execution—have a TM attached. The marker defines a local reference frame where the position of a point, axis, or CAD model of the tool is known (calibrated tool). Navigation is accomplished by executing the following processing steps at every frame time instant: (i). Detect, identify, and estimate the 3D pose C of the WM in camera coordinates using the method in section 4. (ii). If the pose C has been successfully estimated proceed as follows: 1. Detect, identify, and estimate the 3D pose {circumflex over (T)} of the TM in camera coordinates using the method in section 4. 2. If pose {circumflex over (T)} of the surgical instrument is successfully estimated then Compute the 3D pose T of TM in WM coordinates using equation 2. Map the tool calibration information, that can be points, axes, or CAD models, into world coordinates using the rigid transformation T. Relate the tool calibration information with the 3D data stored in memory to make measurements and inferences for the purpose of real-time guidance (e.g. distances and angles between surgical instrument and guides in surgical plan” [0119]).
Regarding Claim 17, Barreto discloses a surgical controller for determining an actual depth of a reamer within a bone, the surgical controller comprising: a processor configured to couple to a display device;a memory coupled to the processor, the memory storing instructions that, when executed by the processor (“(iii) the VR environment shows the drilling direction at each frame time instant such that the surgeon can align it for the exit point to be in the Lateral epicondyle (FIG. 5B), (iv) the tunnel is open along the selected trajectory while VTIAC provides the depth from surface at each frame time instant.” [0152], “VTIAC can be applied in assisting the surgeon in several steps of the execution such as indicating the plane of cut to remove humeral head, or guiding the reaming of humeral shaft and/or glenoid.” [0166]), cause the processor to:
while the reamer is rotating during drilling of the bone, read a portion of a machine- readable pattern on the reamer visible within a surgical site as the reamer translates into the bone, receive one or more images of the visible portion of the reamer, wherein the one or more images comprise a portion of the machine-readable pattern included on the reamer as the reamer rotates (“VTIAC is specially well suited for arthroscopy where the already existing monocular arthroscope acts as the free-moving camera that provides the video input. VTIAC can be successfully employed in any clinical procedure that targets anatomical regions with rigid parts, such as open orthopaedic surgery or dentistry, in which case the operating field must be observed by a camera that can either be attached to a tool or handheld.” [0014], “The small visual markers that are attached to instruments, tools, and anatomy of interest play a fundamental role in VTIAC being key-enablers for using the camera as a measuring device for determining 3D pose.” [0090], “VTIAC shows in a VR environment the registered model and the current orientation of the drilling tool, where this orientation is computed in real-time from the arthroscopic video where both WM and TM can be seen, (iii) the VR environment shows the drilling direction at each frame time instant such that the surgeon can align it for the exit point to be in the Lateral epicondyle (FIG. 5B), (iv) the tunnel is open along the selected trajectory while VTIAC provides the depth from surface at each frame time instant.” [0152]),
determine, based on the portion of the machine-readable pattern included on the reamer, a with the actual depth of the reamer within the bone (“FIG. 6E is an embodiment of using the VTIAC for guiding a perforation or insertion of instrument during PPS. In VR view, the optical axis of the virtual camera is aligned with the desired line of perforation or insertion. The penetration depth displayed is relative to the bone surface at the entry point.” [0042], “VTIAC indicates the location of the footprint by overlaying in video using AR the point in the anatomy where drill tip should be place (the entry point), (ii) VTIAC shows in a VR environment the registered model and the current orientation of the drilling tool, where this orientation is computed in real-time from the arthroscopic video where both WM and TM can be seen, (iii) the VR environment shows the drilling direction at each frame time instant such that the surgeon can align it for the exit point to be in the Lateral epicondyle (FIG. 5B), (iv) the tunnel is open along the selected trajectory while VTIAC provides the depth from surface at each frame time instant.” [0152]);
and display, on the display device, a value indicative of the actual depth of the reamer within the bone (“FIG. 6E is an embodiment of using the VTIAC for guiding a perforation or insertion of instrument during PPS. In VR view, the optical axis of the virtual camera is aligned with the desired line of perforation or insertion. The penetration depth displayed is relative to the bone surface at the entry point.” [0042]).
Barreto does not specifically disclose that the machine-readable pattern comprises a plurality of radial markings along a central axis of the reamer, and wherein the radial markings include annular stripes that at least partially circumscribe the reamer;.
However, in a similar field of endeavor, Stolka teaches a system for image-guided surgery with a medical tool comprising a shaft and a tip, wherein the shaft of the tool includes an optically detectable feature that allows a position of the tip to be determined [Abstract].
Stolka also teaches that the machine-readable pattern comprises a plurality of radial markings spaced apart along a central axis of the reamer, and wherein the radial markings include annular stripes that at least partially circumscribe the reamer (“tracking patterns may include rings on a medical tool, proprietary pseudo-random binary sequence (PRBS) patterns or a De Bruijn sequence applied onto the medical tool shaft. Imaging system 200 may track the medical tool insertion depth visually, using the discernible part of the pattern to identify the medical tool and determine the section and thus the position of the medical tool tip, either uniquely or up to a finite set of discrete possibilities. The determined depth may be overlaid on medical tool guidance displays (e.g., augmented display 220) with one or multiple medical tool-tip candidate locations. The medical tool guidance display may be configured to display a real-time representation of the medical tool including the position of the tip of the medical tool regardless of whether the tip is obstructed or visible. Due to the nature of the pattern, the visual imaging system may correctly calculates the insertion depth when a portion of the pattern is not viewable by the visual imaging system or when only a portion of a minimum length of the pattern is viewable by an imaging system.” [0034]).
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 Barreto as outlined above with the machine-readable pattern comprises a plurality of radial markings spaced apart along a central axis of the reamer, and wherein the radial markings include annular stripes that at least partially circumscribe the reamer as taught by Stolka, because there remains a need for improved imaging devices for use in image-guided surgery [0005].
Regarding Claim 20, Barreto discloses the one or more images are received from a camera associated with an arthroscope (“In terms of clinical applications VTIAC is specially well suited for arthroscopy where the already existing monocular arthroscope acts as the free-moving camera that provides the video input.” [0014]).
Regarding Claim 22, Barreto discloses reading the portion of the machine- readable pattern further comprises: reading the portion of the machine-readable pattern at a first set of coordinates within a coordinate space; receiving bone geometry information mapped within the coordinate space; and determining, based on comparing the first set of coordinates and the bone geometry information, at least one of the actual depth of the reamer and a trajectory of the reamer (“After accessing the anatomical cavity, the surgeon starts by rigidly attaching a marker to the bone surface that is referred as the World Marker (WM).” [0063], “Consider now an instrument or tool with a similar visual marker attached that is referred as Tool Marker (TM). Repeating the process of the previous paragraph the homography HT can be estimated from image information in order to determine the rigid transformation that maps TM coordinates into camera coordinates. If both WM and TM are simultaneously visible in the image, then it is possible to estimate the 3D poses of world and tool markers in the camera frame and find in a straightforward manner the location T of the tool or instrument in the world coordinate system (FIG. 1B)” [0064], “The orientation for opening the tunnel may be determined by registering a statistical model of the femur bone. For this purpose, the surgeon uses the touch probe to reconstruct the boundary contours of the inter-condyle region (FIG. 4B) or, in alternative, to obtain a sparse 3D reconstruction of the surface of the femur bone (FIG. 4C). This 3D data is fed into a suitable 3D registration algorithm that overlays the statistical model with the patient's anatomy. For opening the tunnel the surgeon uses a drill with a TM such that its position can be related in real time with the 3D data stored in memory that includes reconstruction results and the registered statistical model. One possible strategy for guided opening of the tunnel consists in the following: (i) VTIAC indicates the location of the footprint by overlaying in video using AR the point in the anatomy where drill tip should be place (the entry point), (ii) VTIAC shows in a VR environment the registered model and the current orientation of the drilling tool, where this orientation is computed in real-time from the arthroscopic video where both WM and TM can be seen, (iii) the VR environment shows the drilling direction at each frame time instant such that the surgeon can align it for the exit point to be in the Lateral epicondyle (FIG. 5B), (iv) the tunnel is open along the selected trajectory while VTIAC provides the depth from surface at each frame time instant.” [0152]).
Claim 6, & 21 are rejected under 35 U.S.C. 103 as being unpatentable over Barreto in view of Stolka as applied to Claim 1 above, and further in view of Alt et al (US20210023719A1; hereinafter referred to as Alt).
Regarding Claim 6, Barreto in view of Stolka discloses all limitations noted above except that reading the portion of the machine-readable pattern further comprises: identifying a gradient produced by the machine-readable pattern as the reamer rotates; and determining, based on the gradient and a data source, the actual depth of the reamer within the bone.
However, in a similar field of endeavor, Alt teaches a sensor system and method for monitoring and controlling a kinematic chain [0001].
Alt also teaches that reading the portion of the machine-readable pattern further comprises: identifying a gradient produced by the machine-readable pattern as the reamer rotates; and determining, based on the gradient and a data source, the actual depth of the reamer within the bone (“Camera setup and the marker design are carried out as described in section 5. Differently to section 5, rotational markers are mounted onto the motor axis, instead of the joint axis. As a result, the rotational markers 34 may rotate much faster than in other embodiments, which must be considered by the computing unit 5… The amount of angular blurb is determined by a blur estimator. The rotational speed of the motor is given by: r=b/s, where s is the exposure time of the camera. The blur estimator is applied to the angularly sampled signal from the rotation part of the marker, see section 5. With an appropriate blur estimator, any texture can be used on the marker. Radial black-white patterns allow for simple and robust blur estimation.” [0096], “For simple blur estimation, a simple rotational marker 34 may be designed as follows: The rotating part of the marker is implemented as a disk, whereby the circular surface exhibits a sector of e.g. 90° colored black, while the remainder of the circle is white. With blur, the black-white edges are observed as a ramp signal. The angular blur b is the angle increment between the start and the end of this ramp, or it is determined from the slope of the ramp. With a maximal feasible blur of 180°, rotational velocities rps<0.5/s can be measured. Using an auxiliary gear with a transmission ratio 1:n, rps<0.5n/s. The lower limit is given by the minimal detectable blur.” [0097]).
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 Barreto in view of Stolka as outlined above with reading the portion of the machine-readable pattern further comprises: identifying a gradient produced by the machine-readable pattern as the reamer rotates; and determining, based on the gradient and a data source, the actual depth of the reamer within the bone as taught by Alt, because there remains a need for improved image processing when a medical device rotates rapidly [0096].
Regarding Claim 21, Barreto in view of Stolka discloses all limitations noted above except that when the processor determines the value, the instructions further cause the processor to: identify a gradient produced by the machine-readable pattern as the reamer rotates; and determine, based on the gradient and a data source, the actual depth of the reamer within the bone.
However, in a similar field of endeavor, Alt teaches a sensor system and method for monitoring and controlling a kinematic chain [0001].
Alt also teaches that when the processor determines the value, the instructions further cause the processor to: identify a gradient produced by the machine-readable pattern as the reamer rotates; and determine, based on the gradient and a data source, the actual depth of the reamer within the bone (“Camera setup and the marker design are carried out as described in section 5. Differently to section 5, rotational markers are mounted onto the motor axis, instead of the joint axis. As a result, the rotational markers 34 may rotate much faster than in other embodiments, which must be considered by the computing unit 5… The amount of angular blurb is determined by a blur estimator. The rotational speed of the motor is given by: r=b/s, where s is the exposure time of the camera. The blur estimator is applied to the angularly sampled signal from the rotation part of the marker, see section 5. With an appropriate blur estimator, any texture can be used on the marker. Radial black-white patterns allow for simple and robust blur estimation.” [0096], “For simple blur estimation, a simple rotational marker 34 may be designed as follows: The rotating part of the marker is implemented as a disk, whereby the circular surface exhibits a sector of e.g. 90° colored black, while the remainder of the circle is white. With blur, the black-white edges are observed as a ramp signal. The angular blur b is the angle increment between the start and the end of this ramp, or it is determined from the slope of the ramp. With a maximal feasible blur of 180°, rotational velocities rps<0.5/s can be measured. Using an auxiliary gear with a transmission ratio 1:n, rps<0.5n/s. The lower limit is given by the minimal detectable blur.” [0097]).
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 Barreto in view of Stolka as outlined above with when the processor determines the value, the instructions further cause the processor to: identify a gradient produced by the machine-readable pattern as the reamer rotates; and determine, based on the gradient and a data source, the actual depth of the reamer within the bone as taught by Alt, because there remains a need for improved image processing when a medical device rotates rapidly [0096].
Claims 8 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Barreto in view of Stolka as applied to Claim 1 above, and further in view of Kam (US20130090658A1).
Regarding Claim 8, Barreto in view of Stolka discloses all limitations noted above except that the plurality of radial markings are spaced apart by a uniform distances representative of a value of the actual depth.
However, in a similar field of endeavor, Kam teaches a guide pin gauge is described for use in measuring the thickness of an object at a particular location [Abstract].
Kam also teaches that the plurality of radial markings are spaced apart by a uniform distances representative of a value of the actual depth (“the scale is indexed such that the origin of the scale is at said proximal facing shoulder. The guide pin gauge may further comprise markings provided as a second scale, the second scale being indexed such that the origin of the second scale is at a distal extent of the distal cutting head.” [0014], “The scale may include annular rings 80,82 at regular intervals, with at least some of the rings 80,82 further including associated numerical indicators 80,84. The regular intervals may be spaced according to the metric, imperial or any other system of units. The rings 80,82 may not encircle the entire diameter. For example, one side of the guide pin gauge may include a scale arranged in accordance with the metric system while the other side is arranged in accordance with another system of units. Further, one side of the guide pin gauge 1 may include a scale indexed as beginning at the proximal facing shoulder 40 while another side of the guide pin gauge may include a scale indexed as beginning at a distal tip 12 of the distal cutting head 10.” [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 Barreto in view of Stolka as outlined above with the plurality of radial markings are spaced apart by a uniform distances representative of a value of the actual depth as taught by Kam, because it aids in the proper placement of the medical devices and it allows the surgeon to see graphical representations of a placement [0006].
Regarding Claim 14, Barreto in view of Stolka discloses all limitations noted above except that a first portion of a shaft of the reamer including the machine-readable pattern has a smaller diameter than a second portion of the shaft of the reamer including cutting flutes.
However, in a similar field of endeavor, Kam teaches a guide pin gauge is described for use in measuring the thickness of an object at a particular location [Abstract].
Kam also teaches that a first portion of a shaft of the reamer including the machine-readable pattern has a smaller diameter than a second portion of the shaft of the reamer including cutting flutes (“a guide pin gauge is provided comprising a distal cutting head, a proximal shank, and a reduced diameter portion extending a length between the distal cutting head and the proximal shank.” [0011], “outside diameters 14,24 being sufficiently larger than an outside diameter 34 of the reduced diameter portion 30 to produce a sufficient height 48 for the proximal facing shoulder 40.” [0025]).
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 Barreto in view of Stolka as outlined above with a first portion of a shaft of the reamer including the machine-readable pattern has a smaller diameter than a second portion of the shaft of the reamer including cutting flutes the bone as taught by Kam, because it aids in the proper placement of the medical devices and it allows the surgeon to see graphical representations of a placement [0006].
Claims 10-11, & 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Barreto in view of Stolka as applied to Claim 1 above, and further in view of Anderson (US20180140308A1).
Regarding Claim 10, Barreto in view of Stolka discloses all limitations noted above except further comprising:prior to reading the portion of the machine-readable pattern on the reamer, reducing a revolutions per minute of the reamer from a first value to a second value.
However, in a similar field of endeavor, Anderson teaches devices and methods for creating a bore in bone [Abstract].
Anderson also teaches further comprising: prior to reading the portion of the machine-readable pattern on the reamer, reducing a revolutions per minute of the reamer from a first value to a second value (“A user can also proceed until a pop is felt or a change in speed can be heard in the drill. This can be augmented by acceleration or torque measurements provided to the user. For example, as the drill bit penetrates to the very last layers of the distal cortex it can begin to accelerate with a burst of acceleration as it breeches the distal cortex completely, this can also be sensed as a change in torque. In another embodiment, the RPM of the rotational drill motor is kept constant, preventing tool acceleration or deceleration… Upon reaching the predetermined target depth, axial movement of the device can automatically slow or stop while rotational movement can continue. It should be appreciated, however, that the user can manually override any pre-programmed limitations or automated controls by actuation/triggers on the device without changing hand positions to continue.” [0082], “The user can apply pressure axially and engage first the rotational drive motor 60 to the desired speed. The user can proceed to engage the axial drive motor 30 either continuously or incrementally, depending upon the material strength and bone density and preference of the user.” [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 Barreto in view of Stolka as outlined above with further comprising: prior to reading the portion of the machine-readable pattern on the reamer, reducing a revolutions per minute of the reamer from a first value to a second value as taught by Anderson, because it decreases disruptions and delays in orthopedic procedures [0004].
Regarding Claim 11, Barreto in view of Stolka discloses all limitations noted above except further comprising: controlling, based on the actual depth of the reamer within the bone, operation of the reamer.
However, in a similar field of endeavor, Anderson teaches further comprising: controlling, based on the actual depth of the reamer within the bone, operation of the reamer (“A user can also proceed until a pop is felt or a change in speed can be heard in the drill. This can be augmented by acceleration or torque measurements provided to the user. For example, as the drill bit penetrates to the very last layers of the distal cortex it can begin to accelerate with a burst of acceleration as it breeches the distal cortex completely, this can also be sensed as a change in torque. In another embodiment, the RPM of the rotational drill motor is kept constant, preventing tool acceleration or deceleration… Upon reaching the predetermined target depth, axial movement of the device can automatically slow or stop while rotational movement can continue. It should be appreciated, however, that the user can manually override any pre-programmed limitations or automated controls by actuation/triggers on the device without changing hand positions to continue.” [0082])
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 Barreto in view of Stolka as outlined above with further comprising: controlling, based on the actual depth of the reamer within the bone, operation of the reamer as taught by Anderson, because it decreases disruptions and delays in orthopedic procedures [0004].
Regarding Claim 15, Barreto in view of Stolka discloses all limitations noted above except further comprising: displaying, by the surgical controller on the display device, a notification based on whether the value indicative of the actual depth of the reamer within the bone is within a threshold amount from a planned depth or has exceeded a planned depth.
However, in a similar field of endeavor, Anderson teaches further comprising: displaying, by the surgical controller on the display device, a notification based on whether the value indicative of the actual depth of the reamer within the bone is within a threshold amount from a planned depth or has exceeded a planned depth (“The device can further include an alert such that the torque sensor communicates with the programmable electronics package in real-time and the alert provides a user with information regarding status of the driving device during use. The alert can be an auditory, visual or tactile signal.” [0008], “Upon reaching the predetermined target depth, axial movement of the device can automatically slow or stop while rotational movement can continue. It should be appreciated, however, that the user can manually override any pre-programmed limitations or automated controls by actuation/triggers on the device without changing hand positions to continue.” [0082])
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 Barreto in view of Stolka as outlined above with further comprising: displaying, by the surgical controller on the display device, a notification based on whether the value indicative of the actual depth of the reamer within the bone is within a threshold amount from a planned depth or has exceeded a planned depth as taught by Anderson, because it decreases disruptions and delays in orthopedic procedures [0004].
Regarding Claim 16, Barreto in view of Stolka discloses all limitations noted above except further comprising: determining, based on the value of the actual depth, whether a planned depth of the reamer within the bone has been satisfied; and responsive to determining the planned depth has been satisfied, controlling a drill operating the reamer by at least one of electronically stopping a drill operating the reamer and slowing down a speed of the drill.
However, in a similar field of endeavor, Anderson teaches further comprising: determining, based on the value of the actual depth, whether a planned depth of the reamer within the bone has been satisfied; and responsive to determining the planned depth has been satisfied, controlling a drill operating the reamer by at least one of electronically stopping a drill operating the reamer and slowing down a speed of the drill (“The device can further include an alert such that the torque sensor communicates with the programmable electronics package in real-time and the alert provides a user with information regarding status of the driving device during use. The alert can be an auditory, visual or tactile signal.” [0008], “Upon reaching the predetermined target depth, axial movement of the device can automatically slow or stop while rotational movement can continue. It should be appreciated, however, that the user can manually override any pre-programmed limitations or automated controls by actuation/triggers on the device without changing hand positions to continue.” [0082])
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 Barreto in view of Stolka as outlined above with further comprising: determining, based on the value of the actual depth, whether a planned depth of the reamer within the bone has been satisfied; and responsive to determining the planned depth has been satisfied, controlling a drill operating the reamer by at least one of electronically stopping a drill operating the reamer and slowing down a speed of the drill as taught by Anderson, because it decreases disruptions and delays in orthopedic procedures [0004].
Regarding Claim 19, Barreto in view of Stolka discloses all limitations noted above except the instructions further cause the processor to: determine, based on the value of the actual depth, whether a planned depth of the reamer within the bone has been satisfied; and responsive to determining the planned depth has been satisfied, controlling a drill operating the reamer by at least one of electronically stopping a drill operating the reamer and slowing down a speed of the drill.
However, in a similar field of endeavor, Anderson teaches the instructions further cause the processor to: determine, based on the value of the actual depth, whether a planned depth of the reamer within the bone has been satisfied; and responsive to determining the planned depth has been satisfied, controlling a drill operating the reamer by at least one of electronically stopping a drill operating the reamer and slowing down a speed of the drill (“The device can further include an alert such that the torque sensor communicates with the programmable electronics package in real-time and the alert provides a user with information regarding status of the driving device during use. The alert can be an auditory, visual or tactile signal.” [0008], “Upon reaching the predetermined target depth, axial movement of the device can automatically slow or stop while rotational movement can continue. It should be appreciated, however, that the user can manually override any pre-programmed limitations or automated controls by actuation/triggers on the device without changing hand positions to continue.” [0082])
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 Barreto in view of Stolka as outlined above with the instructions further cause the processor to: determine, based on the value of the actual depth, whether a planned depth of the reamer within the bone has been satisfied; and responsive to determining the planned depth has been satisfied, controlling a drill operating the reamer by at least one of electronically stopping a drill operating the reamer and slowing down a speed of the drill as taught by Anderson, because it decreases disruptions and delays in orthopedic procedures [0004].
Regarding Claim 24, Barreto in view of Stolka discloses all limitations noted above except the processor: receives, based on the value, an input; and controls, based on the input, operation of a drill associated with the reamer.
However, in a similar field of endeavor, Anderson teaches the processor: receives, based on the value, an input; and controls, based on the input, operation of a drill associated with the reamer (“A user can also proceed until a pop is felt or a change in speed can be heard in the drill. This can be augmented by acceleration or torque measurements provided to the user. For example, as the drill bit penetrates to the very last layers of the distal cortex it can begin to accelerate with a burst of acceleration as it breeches the distal cortex completely, this can also be sensed as a change in torque. In another embodiment, the RPM of the rotational drill motor is kept constant, preventing tool acceleration or deceleration… Upon reaching the predetermined target depth, axial movement of the device can automatically slow or stop while rotational movement can continue. It should be appreciated, however, that the user can manually override any pre-programmed limitations or automated controls by actuation/triggers on the device without changing hand positions to continue.” [0082])
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 Barreto in view of Stolka as outlined above with the processor: receives, based on the value, an input; and controls, based on the input, operation of a drill associated with the reamer as taught by Anderson, because it decreases disruptions and delays in orthopedic procedures [0004].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Barreto in view of Stolka and further in view of Anderson as applied to Claim 11 above; and further in view of Kam.
Regarding Claim 12, Barreto in view of Stolka and further in view of Anderson discloses all limitations noted above except that the machine-readable pattern is also human- readable.
However, in a similar field of endeavor, Kam teaches that the machine-readable pattern is also human- readable (“the scale is indexed such that the origin of the scale is at said proximal facing shoulder. The guide pin gauge may further comprise markings provided as a second scale, the second scale being indexed such that the origin of the second scale is at a distal extent of the distal cutting head.” [0014], “The scale may include annular rings 80,82 at regular intervals, with at least some of the rings 80,82 further including associated numerical indicators 80,84. The regular intervals may be spaced according to the metric, imperial or any other system of units. The rings 80,82 may not encircle the entire diameter. For example, one side of the guide pin gauge may include a scale arranged in accordance with the metric system while the other side is arranged in accordance with another system of units. Further, one side of the guide pin gauge 1 may include a scale indexed as beginning at the proximal facing shoulder 40 while another side of the guide pin gauge may include a scale indexed as beginning at a distal tip 12 of the distal cutting head 10.” [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 Barreto in view of Stolka as outlined above with the machine-readable pattern is also human- readable as taught by Kam, because it aids in the proper placement of the medical devices and it allows the surgeon to see graphical representations of a placement [0006].
Conclusion
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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