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 .
Response to Arguments
Applicant’s arguments in Applicant’s responses filed 07/27/2026 with respect to the rejection of claims 15-25, and 27 under 35 U.S.C. 103 have been fully considered and are found persuasive. Therefore, the previous rejection has been withdrawn. However, upon further consideration, new grounds of rejections are made in view of newly found prior art, Costales, et al., US 5921992 A.
Specifically, Costales teaches intraoperative calibration of an arbitrary surgical instrument relative to a surgical navigation digitizing system by a calibration guide. The calibration guide is established in position and orientation relative to the digitizing system coordinate system. The surgical instrument is aligned to the calibration guide during calibration to establish its probe and end orientation in the digitizer coordinates. The instrument carries a marker structure which is trackable in the digitizer coordinates to enable tracking by rigid-body transformation of the instruments probe and end position after calibration in the calibration guide. The teachings of Costales have been combined with the teachings of Böhringer, et al., US 20200046454 A1 to arrive at the claimed invention.
Therefore, the claims stand rejected.
Claim Objections
Claim 27 is objected to because of the following informalities:
Claim 27 should be amended to recite …at least one processor to: track the first tracker with the tracking system to determine a first pose of a first tracker…track the second tracker…
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 27 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 appears to include clerical errors such that the recitations of “the first tracker” and “the tracking system” in line 3, and “the second tracker” in line 6 have insufficient antecedence basis. Furthermore, it is unclear if the claim includes single or multiple ones of the recited “first tracker”, “second tracker”, and “tracking system”. The limitations are being interpreted as tracking a first tracker with a tracking system to determine a first pose of the first tracker and tracking a second tracker with the tracking system to determine a positional data of the second tracker.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 15-18 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Böhringer, et al., US 20200046454 A1 (disclosed in IDS filed 01/04/2022) in view of Costales, et al., US 5921992 A.
Regarding claim 15, Böhringer teaches method for determining a radius of a spherically shaped surface portion of a tip of an instrument, wherein the spherically shaped surface portion has a center point ([0017] states that “it is possible to determine or calculate the diameter of the cylindrical, spherical or conical object on the basis how deep the centre of the spherical or cylindrical object can be inserted into the recess (will be explained in detail below)”, the spherical object of an instrument 100 comprising a spherical tip of a dental drill 102 according to [0092]),
wherein a calibration device (registration and identification tool 1 of fig. 1 and [0078]) is provided that comprises a calibration structure defining an opening angle ([0078] states that “The registration and identification tool 1 for a dental and/or cranio-maxillofacial surgical instrument and/or general surgical instrument 100, comprises a body 2, a marker member 3 which is optically detectable, the marker member 3 being detachably provided on the body 2, and a plurality of recesses 4a-e in the body 2, each of which extends from an outer surface of the body 2 into the inside of the body 2”. Also see fig. 6a and [0083] for the conical shape of the recess 4D, which forms an open angle) and that is configured to cooperate with the spherically shaped surface portion so as to guide a tilting movement of the instrument tip around the center point (see fig. 6a and [0092], [0094] for the insertion and pivoting of the spherical tip of the dental drill 102 in the recess 4d),
wherein the calibration device comprises a first tracker (marker member 3 of fig. 1 and [0078] and reference pin 5 of figs. 1-3 and 7-8) trackable by a tracking system (the imaging unit 101 tracks both the reference pin 5 and the marker member 3. NB: either of the marker member 3 and the reference pin 5 comprise the recited first tracker. [0090] states that The surgical instrument 100 comprises the imaging unit 101 which forms part of the registration and identification system. Moreover, the surgical instrument 100 and the imaging unit 101 form part of the navigation system of the invention; and [0034] The registration and identification tool may further comprise a reference pin, wherein a center of the reference pin may preferably be located on a virtual line that is perpendicular to the marker member plane and intersects the marker member centrically in the widthwise direction; [0035] By providing the registration an identification tool with a reference pin, it becomes possible, to calibrate the surgical instrument, in particular the imaging unit of the surgical instrument; and [0054] Further, the processing unit may store information about the relative orientation and/or position between the marker member and the reference pin) and arranged in a predetermined relationship relative to the calibration structure ([0082] discloses that the marker element 3 is placed substantially in the centre of the body 2, thereby dividing the body 2 in a front and a rear part; and with respect to the reference pin 5, [0034] discloses that the registration and identification tool may further comprise a reference pin, wherein a center of the reference pin may preferably be located on a virtual line that is perpendicular to the marker member plane and intersects the marker member centrically in the widthwise direction), and
the method comprising the following steps performed by a computer system:
tracking the first tracker with the tracking system to determine a first pose of the first tracker ([0059] states that “The method comprises the steps of placing a surgical tool of the surgical instrument into the recess of the registration and identification tool, pivoting the surgical instrument relative to the marker member, while the surgical tool is placed inside the recess, performing a detecting process of the relative movement of the surgical instrument, and identifying geometrical characteristics of the surgical tool and/or registering the relative position of the surgical tool to the remainder of the surgical instrument using the results of the detecting process”);
and determining the radius of the spherically shaped surface portion based on the position of the center point, the first pose, the predetermined relationship, and the opening angle ([0093] states that “As the conical shape of the recess 4d is known, in particular the diameter of the recess 4d in relation to the distance from the outer surface of the body 2, it is possible to determine or calculate the diameter of the spherical tip of the dental drill 102 when it is known how deep the centre of the spherical tip was inserted into the conical recess 4d”. The position of the center of the spherical tip is known based how deep the center of the spherical tip was inserted).
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Böhringer teaches the marker member 3 of fig. 1 and [0078] and reference pin 5 of figs. 1-3 and 7-8 as indicated above but does not teach wherein the instrument comprises a second tracker trackable by the tracking system; and determining a position of the center point relative to the second tracker based on the positional data; tracking the second tracker with the tracking system to determine positional data of the second tracker for different tilting positions of the instrument while the spherically shaped surface portion is in abutment with the calibration structure.
However, within the same field of endeavor, Costales teaches intraoperative calibration of an arbitrary surgical instrument relative to a surgical navigation digitizing system by a calibration guide. The calibration guide is established in position and orientation relative to the digitizing system coordinate system. The surgical instrument is aligned to the calibration guide during calibration to establish its probe and end orientation in the digitizer coordinates. The instrument carries a marker structure which is trackable in the digitizer coordinates to enable tracking by rigid-body transformation of the instruments probe and end position after calibration in the calibration guide (see abstract). Costales further teaches wherein the instrument (instrument 28 comprising a probe end 27 col., 1, lines 64-67, and col. 2, lines 1-5) comprises a second tracker trackable by the tracking system(instrument 28 comprising a probe end 27 col., 1, lines 64-67, and col. 2, lines 1-5); and determining a position of the center point relative to the second tracker based on the positional data (col. 3, lines 19-25 indicate that The light markers are determined or tracked by the camera system, so their position and orientation is known in the camera coordinate system. Thus the guide tube position is also known in the camera coordinate system. The probe end 27 of an instrument 28 is inserted or guided by the guide tube 25 so that the tip of the instrument is coincident with point 29, where a tip of the instrument is being interpreted as a center point of the probe end 27 of the instrument 28); tracking the second tracker with the tracking system to determine positional data of the second tracker for different tilting positions of the instrument while the spherically shaped surface portion is in abutment with the calibration structure (col. 3, lines 27-41 disclose light marker elements 32, 33, and 34, or more are attached to the instrument 28, and also registered by the cameras 1. For example, if they are non-colinear, they will have a marker coordinate system associated with them which is also determined relative to the camera coordinate system. Thus, by rigid body transformation from the camera coordinate system, to the marker coordinate system, and to the probe guide, the orientation of the probe direction 27 can be calibrated relative to the cameras in the initial placement in the calibrated guide 25. Thereafter, any motion of the probe or instrument 28 in the field-of-view 8 enables the position of the probe end of the instrument 27 and its tip position to be determined in the camera coordinate system, by the above-mentioned rigid body transformation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Böhringer wherein the instrument comprises a second tracker trackable by the tracking system; and determining a position of the center point relative to the second tracker based on the positional data; tracking the second tracker with the tracking system to determine positional data of the second tracker for different tilting positions of the instrument while the spherically shaped surface portion is in abutment with the calibration structure, as taught by Costales, as such modification would allow effective intraoperative calibration (col. 1, lines 41-48) of any “general and unquantified instrument of arbitrary nature” into “a quantitative, navigable instrument whose position and direction can be tracked by the cameras” (col. 2, lines 26-32) hence potentially reducing overall cost (col. 2, lines 33-38), with a reasonable expectation of success, as Böhringer also concerns itself with precise registration and identification of a surgical instrument [0008].
Regarding claim 16, Böhringer in view of Costales teaches all the limitations of claim 15 above.
Böhringer further teaches determining the radius based on a center distance between the pivot position of the center point, a real or imaginary point relative to which the opening angle is defined and a trigonometric function of the opening angle([0093] states that “As the conical shape of the recess 4d is known, in particular the diameter of the recess 4d in relation to the distance from the outer surface of the body 2, it is possible to determine or calculate the diameter of the spherical tip of the dental drill 102 when it is known how deep the centre of the spherical tip was inserted into the conical recess 4d”. The position of the center of the spherical tip is known based how deep the center of the spherical tip was inserted).
Regarding claim 17, Böhringer in view of Costales teaches all the limitations of claim 15 above.
Böhringer further teaches wherein the positional data comprise at least one of - at least two different tilt poses of the second tracker for the different tilting positions, and - at least four different positions of the second tracker for the different tilting positions (figs. 6a and 6b show pivoting the dental drill 102, which includes the imaging unit 101, in two spatial directions and rotated in one spatial direction which is perpendicular to the other two spatial directs according to [0094]-[0095]).
Regarding claim 18, Böhringer in view of Costales teaches all the limitations of claim 15 above.
Böhringer further teaches wherein the calibration structure has a shape of a cone or a pyramid, or portion thereof, defining the opening angle (see figs. 2 and 6a for the conical shape of the recess 4d. Also see [0092]-[0093] which states that the recess 4d is conical shaped).
Regarding claim 27, Böhringer teaches a computer program product, comprising instructions that, when executed on at least one processor ([0055] discloses that “The processing unit, such as a CPU or the like, may be configured to process imaging data of the imaging unit, i.e., imaging data obtained by the imaging unit”, meaning that the processing unit inherently includes computer program product for performing the steps below), cause the at least one processor to:
track the first tracker (marker member 3 of fig. 1 and [0078] and reference pin 5 of figs. 1-3 and 7-8) with the tracking system to determine a first pose of a first tracker ([0059] states that “The method comprises the steps of placing a surgical tool of the surgical instrument into the recess of the registration and identification tool, pivoting the surgical instrument relative to the marker member, while the surgical tool is placed inside the recess, performing a detecting process of the relative movement of the surgical instrument, and identifying geometrical characteristics of the surgical tool and/or registering the relative position of the surgical tool to the remainder of the surgical instrument using the results of the detecting process”) trackable by a tracking system (the imaging unit 101 tracks both the reference pin 5 and the marker member 3. NB: either of the marker member 3 and the reference pin 5 comprise the recited first tracker. [0090] states that The surgical instrument 100 comprises the imaging unit 101 which forms part of the registration and identification system. Moreover, the surgical instrument 100 and the imaging unit 101 form part of the navigation system of the invention; and [0034] The registration and identification tool may further comprise a reference pin, wherein a center of the reference pin may preferably be located on a virtual line that is perpendicular to the marker member plane and intersects the marker member centrically in the widthwise direction; [0035] By providing the registration an identification tool with a reference pin, it becomes possible, to calibrate the surgical instrument, in particular the imaging unit of the surgical instrument; and [0054] Further, the processing unit may store information about the relative orientation and/or position between the marker member and the reference pin) and arranged in a predetermined relationship relative to a calibration structure of a calibration device ([0082] discloses that the marker element 3 is placed substantially in the centre of the body 2, thereby dividing the body 2 in a front and a rear part; and with respect to the reference pin 5, [0034] discloses that the registration and identification tool may further comprise a reference pin, wherein a center of the reference pin may preferably be located on a virtual line that is perpendicular to the marker member plane and intersects the marker member centrically in the widthwise direction);
wherein the calibration structure is configured to cooperate with the spherically shaped surface portion so as to guide a tilting movement of the instrument tip around a center point (see fig. 6a and [0092], [0094] for the insertion and pivoting of the spherical tip of the dental drill 102 in the recess 4d); and
determine a radius of the spherically shaped surface portion based on the position of the center point, a first pose, the predetermined relationship, and an opening angle defined by the calibration structure ([0093] states that “As the conical shape of the recess 4d is known, in particular the diameter of the recess 4d in relation to the distance from the outer surface of the body 2, it is possible to determine or calculate the diameter of the spherical tip of the dental drill 102 when it is known how deep the centre of the spherical tip was inserted into the conical recess 4d”. The position of the center of the spherical tip is known based on how deep the center of the spherical tip was inserted).
Böhringer teaches the marker member 3 of fig. 1 and [0078] and reference pin 5 of figs. 1-3 and 7-8 as indicated above but does not teach tracking the second tracker with the tracking system to determine positional data of a second tracker trackable by the tracking system for different tilting positions of an instrument while a spherically shaped surface portion of a tip of an instrument is in abutment with the calibration structure; and determine a position of the center point of the spherically shaped surface portion relative to a second tracker based on the positional data.
However, within the same field of endeavor, Costales teaches intraoperative calibration of an arbitrary surgical instrument relative to a surgical navigation digitizing system by a calibration guide. The calibration guide is established in position and orientation relative to the digitizing system coordinate system. The surgical instrument is aligned to the calibration guide during calibration to establish its probe and end orientation in the digitizer coordinates. The instrument carries a marker structure which is trackable in the digitizer coordinates to enable tracking by rigid-body transformation of the instruments probe and end position after calibration in the calibration guide (see abstract). Costales further teaches tracking the second tracker with the tracking system to determine positional data of a second tracker trackable by the tracking system for different tilting positions of an instrument while a spherically shaped surface portion of a tip of an instrument is in abutment with the calibration structure (col. 3, lines 27-41 disclose light marker elements 32, 33, and 34, or more are attached to the instrument 28, and also registered by the cameras 1. For example, if they are non-colinear, they will have a marker coordinate system associated with them which is also determined relative to the camera coordinate system. Thus, by rigid body transformation from the camera coordinate system, to the marker coordinate system, and to the probe guide, the orientation of the probe direction 27 can be calibrated relative to the cameras in the initial placement in the calibrated guide 25. Thereafter, any motion of the probe or instrument 28 in the field-of-view 8 enables the position of the probe end of the instrument 27 and its tip position to be determined in the camera coordinate system, by the above-mentioned rigid body transformation); and determine a position of the center point relative to the second tracker based on the positional data (col. 3, lines 19-25 indicate that The light markers are determined or tracked by the camera system, so their position and orientation is known in the camera coordinate system. Thus the guide tube position is also known in the camera coordinate system. The probe end 27 of an instrument 28 is inserted or guided by the guide tube 25 so that the tip of the instrument is coincident with point 29, where a tip of the instrument is being interpreted as a center point of the probe end 27 of the instrument 28).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Böhringer tracking the second tracker with the tracking system to determine positional data of a second tracker trackable by the tracking system for different tilting positions of an instrument while a spherically shaped surface portion of a tip of an instrument is in abutment with the calibration structure; and determine a position of the center point of the spherically shaped surface portion relative to a second tracker based on the positional data, as taught by Costales, as such modification would allow effective intraoperative calibration (col. 1, lines 41-48) of any “general and unquantified instrument of arbitrary nature” into “a quantitative, navigable instrument whose position and direction can be tracked by the cameras” (col. 2, lines 26-32) hence potentially reducing overall cost (col. 2, lines 33-38), with a reasonable expectation of success, as Böhringer also concerns itself with precise registration and identification of a surgical instrument [0008].
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Böhringer, et al., US 20200046454 A1 (disclosed in IDS filed 01/04/2022) in view of Costales, et al., US 5921992 A, as applied to claim 15 above, and further in view of Tausch, et al., US 20180021092 A2.
Regarding claim 19, Böhringer in view of Costales teaches all the limitations of claim 15.
Böhringer in view of Costales fails to teach comprising determining from a pre-determined list of radii a subset of radii that meet a similarity criterion with respect to the determined radius.
However, within the same field of endeavor, Tausch teaches a calibration tool 1, comprising: two angled supporting surfaces 2 which form a V-shaped notch; and an array 3 which comprises three tracking markers and is rigidly attached to the calibration tool 1 (see reproduced fig. 1 below and [0033]), the calibration tool configured for determining from a pre-determined list of radii a subset of radii that meet a similarity criterion with respect to the determined radius ([0040] states that “a calibration tool 1 which is provided can comprise a plurality of supporting surfaces 2 which are configured to abut against the tip of a hollow distal section 7 of a medical instrument 5. Since the calibration tool 1 and the proximal section of the instrument 5 are tracked, geometrical data regarding the diameter of the instrument tip can be obtained by measuring the distance between the tracking marker array 3 on the calibration tool 1 and the tracking marker array 6 on the proximal section of the instrument 5. If the inner diameter of the hollow tip exceeds a predetermined value, the tip will fit over the upper cylindrical section of the calibration tool 1 and abut against the circular supporting surface 2. If the inner diameter of the hollow tip of the instrument 5 does not exceed said predetermined value, the tip will abut against the tapered supporting surface 2 provided within the upper cylindrical section of the calibration tool 1. The lower the value of the outer diameter of the instrument tip, the further down the instrument tip can be inserted onto the tapered supporting surface 2, such that geometrical data regarding the outer diameter of the instrument tip can be obtained by measuring the distance between the tracking reference array 3 and the tracking reference array 6”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Böhringer for determining from a pre-determined list of radii a subset of radii that meet a similarity criterion with respect to the determined radius, as taught by Tausch, to provide an efficient and reliable method for identifying a medical instrument to be used during computer-assisted surgery ([0004]-[0005]), with a reasonable expectation of success, as Böhringer also concerns itself with precise registration and identification of a surgical instrument [0008].
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Regarding claim 20, Böhringer in view of Costales and Tausch teaches all the limitations of claim 19.
Böhringer in view of Costales fails to teach comprising generating an output for a user selection or confirmation, wherein the output comprises at least one of information about the subset of radii and information about instrument tips associated with the subset of radii.
However, Tausch further teaches generating an output for a user selection or confirmation, wherein the output comprises at least one of information about the subset of radii and information about instrument tips associated with the subset of radii ([0027] states that “The navigation system also preferably comprises a user interface for receiving the calculation results from the computer (for example, the position of the main plane, the position of the auxiliary plane and/or the position of the standard plane). The user interface provides the received data to the user as information. Examples of a user interface include a display device such as a monitor, or a loudspeaker. The user interface can use any kind of indication signal (for example a visual signal, an audio signal and/or a vibration signal). One example of a display device is an augmented reality device (also referred to as augmented reality glasses) which can be used as so-called “goggles” for navigating. A specific example of such augmented reality glasses is Google Glass (a trademark of Google, Inc.). An augmented reality device can be used both to input information into the computer of the navigation system by user interaction and to display information outputted by the computer”. See [0040] for the information regarding the radii of the instrument tip).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Böhringer for generating an output for a user selection or confirmation, wherein the output comprises at least one of information about the subset of radii and information about instrument tips associated with the subset of radii, as taught by Tausch, to provide an efficient and reliable method for identifying a medical instrument to be used during computer-assisted surgery ([0004]-[0005]), with a reasonable expectation of success, as Böhringer also concerns itself with precise registration and identification of a surgical instrument [0008].
Claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Böhringer, et al., US 20200046454 A1 (disclosed in IDS filed 01/04/2022) in view of Costales, et al., US 5921992 A, as applied to claim 15 above, and further in view of Andersson, M., US 20180289433 A1.
Regarding claim 21, Böhringer in view of Costales teaches all the limitations of claim 15.
Böhringer fails to teach tracking a third tracker of an object and trackable by the tracking system to track an object pose of image data of the object in a virtual space; tracking the second tracker to track a position of the center point in the virtual space based on the position of the center point relative to the second tracker; and generating first display instructions for displaying in the virtual space, based on the object pose of the image data of the object in the virtual space, the position of the center point in the virtual space and the radius, a visual representation indicative of the radius relative to the image data of the object.
However, within the same field of endeavor, Andersson teaches tracking a current position and orientation of a surgical object using a surgical navigation system; and providing feedback of a current position and orientation of the surgical object relative to a planned position and orientation of a virtual object based on the tracked current position and orientation of the surgical object ([0015]), the tracking including determining the position of a navigation unit of the calibration unit, the navigation unit having a fixed positional relationship relative the surface with a predetermined position. Optionally or additionally calibrating the position of the navigation unit of the surgical object may comprise registering multiple positions of the navigation unit of the surgical object while it is moved in at least one plane and the position of the end-effector is substantially fixed at the surface with the predetermined position, and determining the position of the end-effector based on the registered multiple positions of the navigation unit of the surgical object ([0018]). Anderson further teaches tracking a third tracker of an object and trackable by the tracking system to track an object pose of image data of the object in a virtual space ([0093] suggests calibrating various instruments and devices. Figs. 10a-10c and [1117]-[0118] disclose navigation units 112b with respect to a position registration unit 18 (position sensor or position registration probe), whereby positions of a surface of a patient are detected and registered; and [0118] also describes navigation units 112c and 112d for attachment to the patient, whereby the patient is tracked. The navigation units 112b, 112c, and 112d comprise the recited third tracker which are tracked within a virtual environment [0117]);
tracking the second tracker to track a position of the center point in the virtual space based on the position of the center point relative to the second tracker ([0093] suggests calibrating various instruments and devices, and figs. 10a-10c and [0115]-[0116] disclose the navigation unit 112a associated with the surgical instrument 93 and that the position and orientation of the navigation unit 112a including a center point [0085] relative to the surgical object may be determined and tracked. The navigation unit 112a comprises the claimed second tracker that is associated with the instrument); and
generating first display instructions for displaying in the virtual space, based on the object pose of the image data of the object in the virtual space, the position of the center point in the virtual space and the radius, a visual representation indicative of the radius relative to the image data of the object ([0125] states that “The surgical navigation system also comprises a feedback unit, such as a display 300. The patient structure may be aligned with the virtual structure, such as described above. Utilizing the components of the surgical navigation system, the position of the surgical object relative to the pre-operative plan and the patient structure may be tracked in real-time, such as illustrated in FIG. 11c, wherein the position of the virtual object is displayed in relation to the virtual structure in the same relationship as the surgical object 93 to the patient structure.” [0121] state that “The registered positions of the navigation unit 112a forms a shape, such as a dome shape, having an origin located at the position of the end-effector 195 and with a radius determined by the distance between the origin and the registered positions. Hence, the registered positions of the navigation unit 112a may be used to determine the position of the end-effector 195 and the longitudinal axis of the instrument or tool. In FIG. 11e, the surgical object 93 is shown in multiple positions for illustrative purposes”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Böhringer to track a third tracker of an object and trackable by the tracking system to track an object pose of image data of the object in a virtual space; tracking the second tracker to track a position of the center point in the virtual space based on the position of the center point relative to the second tracker; and generating first display instructions for displaying in the virtual space, based on the object pose of the image data of the object in the virtual space, the position of the center point in the virtual space and the radius, a visual representation indicative of the radius relative to the image data of the object, as taught by Andersson, so that by calibrating the navigation unit 112a of the surgical object, and thus the position of the end-effector, the accuracy, robustness, and reliability, and flexibility of the system is enhanced compared to an uncalibrated system or a system wherein the calibration is based on scanning the surgical object and registering against CAD objects according to [0125], with a reasonable expectation of success, as Böhringer also concerns itself with precise registration and identification of a surgical instrument [0008].
Regarding claim 22, Böhringer in view of Costales teaches all the limitations of claim 15.
Böhringer in view of Costales fails to teach generating region display instructions for displaying a non-target region in the image data for which contact with the instrument is to be avoided.
However, Anderson further teaches generating region display instructions for displaying a non-target region in the image data for which contact with the instrument is to be avoided (see fig. 9 and [0112] which disclose a feedback system that indicates as a trace 81, tracked positions and orientations of the surgical object in a second coordinate system such that the surgeon is guided from the deviation trace 81 back to the planned trajectory 41 before an entry position 42. This deviation correction is tantamount to the claimed displayed non-target region in the image data for which contact with the instrument is to be avoided).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Böhringer for generating region display instructions for displaying a non-target region in the image data for which contact with the instrument is to be avoided, as taught by Andersson, so that by calibrating the navigation unit 112a of the surgical object, and thus the position of the end-effector, the accuracy, robustness, and reliability, and flexibility of the system is enhanced compared to an uncalibrated system or a system wherein the calibration is based on scanning the surgical object and registering against CAD objects according to [0125], with a reasonable expectation of success, as Böhringer also concerns itself with precise registration and identification of a surgical instrument [0008].
Regarding claim 23, Böhringer in view of Costales teaches all the limitations of claim 15.
Böhringer fails to teach comprising generating progress display instructions for displaying a progress of object manipulation based on a path of the instrument tip.
However, Anderson further teaches generating progress display instructions for displaying a progress of object manipulation based on a path of the instrument tip (see fig. 9 and [0112]-[0113] which disclose a feedback system that indicates as a trace 81, tracked positions and orientations of the surgical object in a second coordinate system such that the surgeon is guided from the deviation trace 81 back to the planned trajectory 41 before an entry position 42. The feedback system displays the trace 81 and is able to verify a correct position and orientation of the tracked object).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Böhringer for generating progress display instructions for displaying a progress of object manipulation based on a path of the instrument tip, as taught by Andersson, so that by calibrating the navigation unit 112a of the surgical object, and thus the position of the end-effector, the accuracy, robustness, and reliability, and flexibility of the system is enhanced compared to an uncalibrated system or a system wherein the calibration is based on scanning the surgical object and registering against CAD objects according to [0125], with a reasonable expectation of success, as Böhringer also concerns itself with precise registration and identification of a surgical instrument [0008].
Regarding claim 24, Böhringer in view of Costales teaches all the limitations of claim 15.
Böhringer in view of Costales fails to teach comprising displaying, on a display, a visual representation of at least a portion of the instrument relative to the image data of the object.
However, Anderson further teaches displaying, on a display, a visual representation of at least a portion of the instrument relative to the image data of the object (see fig. 8 and [0111] which disclose a virtual object in the form of a virtual surgical instrument 80 is shown in the display).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Böhringer for displaying, on a display, a visual representation of at least a portion of the instrument relative to the image data of the object, as taught by Andersson, so that by calibrating the navigation unit 112a of the surgical object, and thus the position of the end-effector, the accuracy, robustness, and reliability, and flexibility of the system is enhanced compared to an uncalibrated system or a system wherein the calibration is based on scanning the surgical object and registering against CAD objects according to [0125], with a reasonable expectation of success, as Böhringer also concerns itself with precise registration and identification of a surgical instrument [0008].
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Böhringer, et al., US 20200046454 A1 (disclosed in IDS filed 01/04/2022) in view of Costales, et al., US 5921992 A, as applied to claim 15 above, and further in view of Krueger, et al., US 20140314297 A1.
Regarding claim 25, Böhringer in view of Costales teaches all the limitations of claim 15.
Böhringer in view of Costales fails to teach wherein the visual representation comprises an icon representative of at least a part of a circle or a sphere with the radius of the spherically shaped surface portion.
However, Krueger teaches a method for assigning position values, detected by means of a position detection system, to a topographic image of an object or body part, which comprises the following steps: providing a topographic model of an object or body part, scanning a surface of the object or body, detecting position values during the scanning and assigning detected position values to corresponding positions in the topographic model, the detected position values being assigned to points of a virtual surface of the topographic model, which has a distance from a model surface which corresponds to a radius of a partly spherical scanning tip of a scanning instrument, by means of which the surface of the object or body part is scanned in each case (see abstract), wherein the visual representation comprises an icon representative of at least a part of a circle or a sphere with the radius of the spherically shaped surface portion ([0006]-[0009] disclose “assigning detected position values to corresponding positions in the topographic model, the detected position values being assigned to points of a virtual surface of the topographic model, which has a distance from a model surface which corresponds to a radius of a partly spherical scanning tip of a scanning instrument, by means of which the surface of the object or body part is scanned in each case”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Böhringer wherein the visual representation comprises an icon representative of at least a part of a circle or a sphere with the radius of the spherically shaped surface portion, as taught by Krueger, as such modification would improve detection of the positions and orientations of the tip of the instruments with respect to the tissue [0012], with a reasonable expectation of success, as Böhringer also concerns itself with precise registration and identification of a surgical instrument [0008].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sheffer, et al., US 20070038059 A1 discloses an instrument morphing/calibration process (see figs. 9-11) where data is collected and analyzed along the surface of instrument 705 (shown here as a cutting block) by touching or registering probe 710 against instrument 705 at a plurality of select surface points 715.
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.
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/FAROUK A BRUCE/ Examiner, Art Unit 3797
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