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 filed 04/24/2025 have been fully considered but they are not persuasive.
Per the amendments to claims 24-25, the use of Dall has been maintained. Because the tip of the needle is continuously determined to be the current entry point, there exist scenarios in which the current entry point is determined while the claimed conditions are satisfied.
Applicant argues, see Applicant’s arguments pages 7-11, that Dall does not teach “determining as a threshold value a predetermined percentage of a distance between the planned entry point and the target” and the combination of Dall with Boctor comprises hindsight reasoning. Examiner asserts that Applicant’s arguments misrepresent the reason for introducing threshold TH2 of Dall. Threshold TH2 was not intended to replace threshold TH1, merely that the means of determining threshold TH2 comprise considering the distance between the planned entry point and target point. Dall does not disclose how threshold TH1 is determined; [0031] merely provides an exemplary value of 3 mm. From this, it can only be assumed that threshold TH1 is a static value. However, depending on the relative depth of the target point from the surface of the patient, the preciseness of the distance between the current entry point from the planned entry point, which threshold TH1 defines, may change. Thus, a static value of 3 mm may not be sufficient in some patients. Threshold TH2 was introduced to show that Dall teaches that a threshold can be determined based on a distance between the planned entry point and the target point. One having ordinary skill in the art would understand that a static value for threshold TH1 is less desirable than one that considers the distance between the planned entry point and the target point, and look to threshold TH2 for a threshold whose value depends on this distance. Examiner asserts that, with the disclosure of how threshold TH2 is determined, one having ordinary skill in the art would be motivated and understand how to modify the determination of threshold TH1 such that it changes based on the distance between the planned entry point and the target point. Nevertheless, the language of the motivation statement in claim 1 has been disambiguated to more clearly define the purpose for introducing threshold TH2.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 4-5, 17-20, & 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Boctor (US 2013/0218024) in view of Dall (EP 2716252).
Regarding claim 1, Boctor teaches a computer-implemented method of controlling display of a navigation view for navigation of a surgical instrument, the method comprising:
obtaining planning data defining a planned entry point (planned insertion point, [0187]) for the surgical instrument (needle, [0223]) and a planned target (target, [0187]) for the surgical instrument, wherein the planned entry point and the planned target are defined in a coordinate system (explicit fixed reference coordinate system, [0214]) of a computer model (computational model, [0211]) of at least one anatomical element ([0211]);
Paragraph [0211] teaches that the computational model is based on surface models from the ultrasound and camera systems; thus, the anatomical element would be the patient’s skin surface.
obtaining tracking data describing a current pose (current needle position and orientation, [0223]) of the surgical instrument in the coordinate system;
determining, based on at least the tracking data, a current entry point (projected needle entry point, [0223]) lying on a trajectory having a fixed spatial relationship with the surgical instrument ([0223]); and
controlling display of a navigation view visualizing at least a recommended entry point for the surgical instrument ([0187] & [0224]).
However, Boctor fails to disclose: determining as a threshold value a predetermined percentage of a distance between the planned entry point and the target; determining that a distance between the planned entry point and the current entry point is lower than the threshold value; such that the recommended entry point is instantaneously changed from the planned entry point to the current entry point responsive to determining that the distance between the planned entry point and the current entry point is lower than the threshold value.
Dall teaches:
determining that a distance (distance D1, [0030]) between the planned entry point (entry point PE, [0030]) and the current entry point (current position of the tip 1a of the needle 1, [0030]) is lower than a threshold value (threshold TH1, [0032]);
such that the recommended entry point is instantaneously changed from the planned entry point to the current entry point responsive to determining that the distance between the planned entry point and the current entry point is lower than a threshold value ([0032]).
As taught in [0032], once the position of the needle is within the distance threshold to the planned entry point, the process moves to the next step of orienting the needle. Therefore, because the new entry point is accepted and used for the rest of the procedure, it can be considered that it has been “instantaneously changed” from the planned entry point.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Boctor to include: determining that a distance between the planned entry point and the current entry point is lower than a threshold value; such that the recommended entry point is instantaneously changed from the planned entry point to the current entry point responsive to determining that the distance between the planned entry point and the current entry point is lower than the threshold value, as taught by Dall. Allowing the entry point to deviate slightly from the planned entry point ensures that the procedure proceeds steadily, as the operator is not required to spend an abundance of time locating the planned entry point with exact, pinpoint accuracy.
A further embodiment of Dall teaches determining as a threshold value (threshold TH2, [0034]) a predetermined percentage of a distance between the planned entry point and the target (“threshold TH2 with the value depending on…the distance between entry point PE and target point PT”, [0034]).
Although [0034] does not definitively state that threshold TH2 is a percentage of the distance between entry point PE and target point PT, configuring threshold TH2 to be a percentage of this distance based on the disclosure that it is a “value depending on the distance” would be the simplest, most obvious interpretation. Nevertheless, one having ordinary skill in the art would be able to modify either threshold TH1 or threshold TH2 to be a predetermined percentage of a distance between the planned entry point and the target (or any other value) to determine an optimal threshold value via routine optimization. See MPEP 2144.05, IIA.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified threshold TH1 of the first embodiment of Dall to be determined as a predetermined percentage of a distance between the planned entry point and the target, like the threshold TH2 of the second embodiment of Dall. The depth of the target point from the entry point will vary from patient to patient; thus, using a threshold that considers this distance will result in a more accurate insertion process. Additionally, using a different threshold value will not change how the procedure is performed.
Regarding claim 4, Boctor in view of Dall teach the method of claim 1, and Dall further teaches that the current entry point lies on a tip of the surgical instrument ([0030]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Boctor such that the current entry point lies on a tip of the surgical instrument, as taught by Dall. Defining the current entry point as a point on the surgical instrument more easily allows it to be tracked.
Regarding claim 5, Boctor in view of Dall teach the method of claim 1, and Boctor further teaches that the trajectory is essentially parallel to a longitudinal axis of the surgical instrument ([0223]).
Per [0223], the projected entry point is determined based on the projected extension of the needle shaft; therefore, the trajectory was used for this determination would be parallel to the longitudinal axis of the needle.
Regarding claim 17, Boctor in view of Dall teach the method of claim 1, and Dall further teaches that the recommended entry point is permanently changed from the planned entry point to the current entry responsive to determining that the distance between the planned entry point and the current entry point is lower than the threshold value ([0032]).
As taught in [0032], once the position of the needle is within the distance threshold to the planned entry point, the process moves to the next step of orienting the needle. Therefore, because the new entry point is accepted and used for the rest of the procedure, it can be considered that it has been “permanently changed” from the planned entry point.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Boctor such that the recommended entry point is permanently changed from the planned entry point to the current entry responsive to determining that the distance between the planned entry point and the current entry point is lower than the threshold value, as taught by Dall. Updating the entry point allows the system to recalculate the orientation and insertion depth of the procedure, ensuring the target can still be reached despite the deviation in the planned entry point location.
Regarding claim 18, Boctor in view of Dall teach the method of claim 1, and Dall further teaches that the recommended entry point is instantaneously reset from the current entry point to the planned entry point, upon the distance between the planned entry point and the current entry point no longer fulfilling a predefined criterion ([0014] & [0030]).
Entry point PE is the point to which the navigation is directed. If the operator navigates to within the threshold distance to entry point PE but later strays from this distance, the navigation will continue to be directed to this point, as [0014] states that this is the point that is stored in the memory.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Boctor such that the recommended entry point is instantaneously reset from the current entry point to the planned entry point, upon the distance between the planned entry point and the current entry point no longer fulfilling a predefined criterion, as taught by Dall. Resetting the navigation point to the planned entry point ensures that the guidance remains centered on the planned entry point even after several unsuccessful attempts.
Regarding claim 19, Boctor teaches a processor for a surgical navigation system, the processor configured to:
obtain planning data defining a planned entry point (planned insertion point, [0187]) for the surgical instrument (needle, [0223]) and a planned target (target, [0187]) for the surgical instrument, wherein the planned entry point and the planned target are defined in a coordinate system (explicit fixed reference coordinate system, [0214]) of a computer model (computational model, [0211]) of at least one anatomical element ([0211]);
Paragraph [0211] teaches that the computational model is based on surface models from the ultrasound and camera systems; thus, the anatomical element would be the patient’s skin surface.
obtain tracking data describing a current pose (current needle position and orientation, [0223]) of the surgical instrument in the coordinate system;
determine, based on at least the tracking data, a current entry point (projected needle entry point, [0223]) lying on a trajectory having a fixed spatial relationship with the surgical instrument ([0223]); and
control display of a navigation view visualizing at least a recommended entry point for the surgical instrument ([0187] & [0224]).
However, Boctor fails to disclose: determining as a threshold value a predetermined percentage of a distance between the planned entry point and the target; determining that a distance between the planned entry point and the current entry point is lower than the threshold value; such that the recommended entry point is instantaneously changed from the planned entry point to the current entry point responsive to determining that the distance between the planned entry point and the current entry point is lower than the threshold value.
Dall teaches:
determining that a distance (distance D1, [0030]) between the planned entry point (entry point PE, [0030]) and the current entry point (current position of the tip 1a of the needle 1, [0030]) is lower than a threshold value (threshold TH1, [0032]);
such that the recommended entry point is instantaneously changed from the planned entry point to the current entry point responsive to determining that the distance between the planned entry point and the current entry point is lower than a threshold value ([0032]).
As taught in [0032], once the position of the needle is within the distance threshold to the planned entry point, the process moves to the next step of orienting the needle. Therefore, because the new entry point is accepted and used for the rest of the procedure, it can be considered that it has been “instantaneously changed” from the planned entry point.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Boctor to include: determining that a distance between the planned entry point and the current entry point is lower than a threshold value; such that the recommended entry point is instantaneously changed from the planned entry point to the current entry point responsive to determining that the distance between the planned entry point and the current entry point is lower than the threshold value, as taught by Dall. Allowing the entry point to deviate slightly from the planned entry point ensures that the procedure proceeds steadily, as the operator is not required to spend an abundance of time locating the planned entry point with exact, pinpoint accuracy.
A further embodiment of Dall teaches determining as a threshold value (threshold TH2, [0034]) a predetermined percentage of a distance between the planned entry point and the target (“threshold TH2 with the value depending on…the distance between entry point PE and target point PT”, [0034]).
Although [0034] does not definitively state that threshold TH2 is a percentage of the distance between entry point PE and target point PT, configuring threshold TH2 to be a percentage of this distance based on the disclosure that it is a “value depending on the distance” would be the simplest, most obvious interpretation. Nevertheless, one having ordinary skill in the art would be able to modify either threshold TH1 or threshold TH2 to be a predetermined percentage of a distance between the planned entry point and the target (or any other value) to determine an optimal threshold value via routine optimization. See MPEP 2144.05, IIA.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified threshold TH1 of the first embodiment of Dall to be threshold TH2 of the second embodiment of Dall. The depth of the target point from the entry point will vary from patient to patient; thus, using a threshold that considers this distance will result in a more accurate insertion process. Additionally, using a different threshold value will not change how the procedure is performed.
Regarding claim 20, Boctor teaches a computer-readable medium comprising a computer program, the computer program comprising instructions which, when the program is executed by a processor, cause the processor to:
obtain planning data defining a planned entry point (planned insertion point, [0187]) for the surgical instrument (needle, [0223]) and a planned target (target, [0187]) for the surgical instrument, wherein the planned entry point and the planned target are defined in a coordinate system (explicit fixed reference coordinate system, [0214]) of a computer model (computational model, [0211]) of at least one anatomical element ([0211]);
Paragraph [0211] teaches that the computational model is based on surface models from the ultrasound and camera systems; thus, the anatomical element would be the patient’s skin surface.
obtain tracking data describing a current pose (current needle position and orientation, [0223]) of the surgical instrument in the coordinate system;
determine, based on at least the tracking data, a current entry point (projected needle entry point, [0223]) lying on a trajectory having a fixed spatial relationship with the surgical instrument ([0223]); and
control display of a navigation view visualizing at least a recommended entry point for the surgical instrument ([0187] & [0224]).
However, Boctor fails to disclose: determining as a threshold value a predetermined percentage of a distance between the planned entry point and the target; determining that a distance between the planned entry point and the current entry point is lower than the threshold value; such that the recommended entry point is instantaneously changed from the planned entry point to the current entry point responsive to determining that the distance between the planned entry point and the current entry point is lower than the threshold value.
Dall teaches:
determining that a distance (distance D1, [0030]) between the planned entry point (entry point PE, [0030]) and the current entry point (current position of the tip 1a of the needle 1, [0030]) is lower than a threshold value (threshold TH1, [0032]);
such that the recommended entry point is instantaneously changed from the planned entry point to the current entry point responsive to determining that the distance between the planned entry point and the current entry point is lower than a threshold value ([0032]).
As taught in [0032], once the position of the needle is within the distance threshold to the planned entry point, the process moves to the next step of orienting the needle. Therefore, because the new entry point is accepted and used for the rest of the procedure, it can be considered that it has been “instantaneously changed” from the planned entry point.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Boctor to include: determining that a distance between the planned entry point and the current entry point is lower than a threshold value; such that the recommended entry point is instantaneously changed from the planned entry point to the current entry point responsive to determining that the distance between the planned entry point and the current entry point is lower than the threshold value, as taught by Dall. Allowing the entry point to deviate slightly from the planned entry point ensures that the procedure proceeds steadily, as the operator is not required to spend an abundance of time locating the planned entry point with exact, pinpoint accuracy.
A further embodiment of Dall teaches determining as a threshold value (threshold TH2, [0034]) a predetermined percentage of a distance between the planned entry point and the target (“threshold TH2 with the value depending on…the distance between entry point PE and target point PT”, [0034]).
Although [0034] does not definitively state that threshold TH2 is a percentage of the distance between entry point PE and target point PT, configuring threshold TH2 to be a percentage of this distance based on the disclosure that it is a “value depending on the distance” would be the simplest, most obvious interpretation. Nevertheless, one having ordinary skill in the art would be able to modify either threshold TH1 or threshold TH2 to be a predetermined percentage of a distance between the planned entry point and the target (or any other value) to determine an optimal threshold value via routine optimization. See MPEP 2144.05, IIA.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified threshold TH1 of the first embodiment of Dall to be threshold TH2 of the second embodiment of Dall. The depth of the target point from the entry point will vary from patient to patient; thus, using a threshold that considers this distance will result in a more accurate insertion process. Additionally, using a different threshold value will not change how the procedure is performed.
Regarding claim 24, Boctor in view of Dall teach the method of claim 1, and Dall further teaches determining as the current entry point an intersection between the trajectory and a line that is perpendicular to the trajectory and passes through the planned entry point ([0030] & Figure 4).
As is shown in Figure 4, the axis of the needle is perpendicular to D1, the distance from the planned entry point PE and the tip of the needle (current entry point). Because the tip of the needle is determined to be the current entry point (i.e., continuously determined), the spatial arrangement depicted in Figure 4 reads on the claim—the current entry point is determined at a time that the claimed conditions are satisfied.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Boctor to include determining as the current entry point an intersection between the trajectory and a line that is perpendicular to the trajectory and passes through the planned entry point, as taught by Dall. It is expected that a line perpendicular to the trajectory of the needle that passes through the current entry point will lie on the surface of the patient. In doing so, the system can determine the point that the needle will enter the patient.
Regarding claim 25, Boctor in view of Dall teach the method of claim 1, and Dall further teaches determining as the current entry point an intersection between the trajectory and a plane that includes the planned entry point and has a normal defined by a straight line between the planned entry point and the planned target ([0033] & Figure 5).
Figure 5 depicts a scenario in which the tip of the needle (current entry point) is placed on the planned entry point PE. In this scenario, because the current and planned entry points occupy the same spatial point, the claimed conditions are satisfied. Nevertheless, even if the current entry point is not placed precisely on the planned entry point, there will exist a time in the insertion process in which the tip of the needle intersects a plane that includes the planned entry point and has a normal defined by a straight line between the planned entry point and the planned target. In either of these scenarios, the current entry point is determined at a time that the claimed conditions are satisfied.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Boctor to include determining as the current entry point an intersection between the trajectory and a plane that includes the planned entry point and has a normal defined by a straight line between the planned entry point and the planned target, as taught by Dall. This plane provides a frame of reference by which to measure the distance between the planned entry point and the current entry point.
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Boctor in view of Dall, as applied to claim 1, above, in further view of Urquhart (US 2005/0049486).
Regarding claims 6-8, Boctor in view of Dall teach the method of claim 1, and Boctor further teaches that the navigation view visualizes the recommended entry point by aligning or orienting the navigation view with respect to the recommended entry point ([0187] & Figure 8).
However, Boctor in view of Dall fail to disclose that the navigation view visualizes the recommended entry point and the planned target by aligning or orienting the navigation view with respect to the recommended entry point.
Urquhart teaches that the navigation view (Figure 12) visualizes the recommended entry point (desired entry point 128, [0084]) and the planned target (target 114, [0084]) by aligning or orienting the navigation view with respect to the recommended entry point ([0084]).
As discussed in [0084], the plurality of rings or circles 129, illustrated in Figure 12, represent the trajectory of the lead 70 with respect to the desired entry point 128 and the target 114. The desired trajectory has been achieved once the circles are concentrically aligned.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Boctor and Dall such that the navigation view visualizes the recommended entry point and the planned target by aligning or orienting the navigation view with respect to the recommended entry point, as taught by Urquhart. Visualizing the entry point and target allows the operator to understand the relative location of the target prior to the procedure.
Regarding claims 9-10, Boctor in view of Dall teach the method of claim 1.
However, Boctor in view of Dall fail to disclose that the navigation view has a viewing direction corresponding to a straight line between the recommended entry point and the planned target, wherein the navigation view is a bullseye view centered on a straight line between the recommended entry point and the planned target.
Urquhart teaches that the navigation view has a viewing direction corresponding to a straight line between the recommended entry point and the planned target ([0084] & Figure 12), wherein the navigation view is a bullseye view centered on a straight line between the recommended entry point and the planned target ([0084] & Figure 12).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Boctor and Dall such that the navigation view has a viewing direction corresponding to a straight line between the recommended entry point and the planned target, wherein the navigation view is a bullseye view centered on a straight line between the recommended entry point and the planned target, as taught by Urquhart. Presenting the navigation view as a bullseye view allows any deviation from the planned orientation to be easily recognized and corrected.
Claims 11 & 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Boctor in view of Dall, as applied to claim 1, above, in further view of Ayvali (US 2021/0196399).
Regarding claim 11, Boctor in view of Dall teach the method of claim 1.
However, Boctor in view of Dall fail to disclose that the navigation view comprises a visualization of a relative spatial relationship between the surgical instrument and the planned target.
Ayvali teaches (Figures 6-4, 6-5, & 6-6) that the navigation view comprises a visualization (progress bar 636, [0127]) of a relative spatial relationship between the surgical instrument (needle 170, [0127]) and the planned target (target location 664, [0127]).
Although Ayvali has a filing date of 12/22/2020, it claims dependency on a provisional application (US 62/956,019) dated 12/31/2019. The cited paragraphs are supported in full in the provisional application.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Boctor and Dall such that the navigation view comprises a visualization of a relative spatial relationship between the surgical instrument and the planned target, as taught by Ayvali. Providing a visualization of the distance to the target from the entry point allows the operator to understand the necessary insertion depth to reach the target.
Regarding claims 13-16, Boctor in view of Dall teach the method of claim 1.
However, Boctor in view of Dall fail to disclose that the navigation view comprises a visualization of a fraction determined by dividing a first distance by a second distance or the second distance by the first distance, wherein the first distance is a distance between a position of the surgical instrument in the coordinate system and the target, and wherein the second distance is a distance between the recommended entry point and the target, wherein the visualization of the fraction is a progress bar, wherein the progress bar is concentrically formed around an alignment point in the navigation view, wherein the alignment point lies on a straight line between the recommended entry point and the planned target.
Ayvali teaches that the navigation view comprises a visualization of a fraction determined by dividing a first distance by a second distance or the second distance by the first distance, wherein the first distance is a distance between a position of the surgical instrument in the coordinate system and the target, and wherein the second distance is a distance between the recommended entry point and the target ([0127] & Figures 6-4, 6-5, & 6-6), wherein the visualization of the fraction is a progress bar (progress bar 636, [0127]), wherein the progress bar is concentrically formed around an alignment point in the navigation view ([0127] & Figures 6-4, 6-5, & 6-6), wherein the alignment point lies on a straight line between the recommended entry point and the planned target (Figures 6-4, 6-5, & 6-6).
Paragraph [0127] states “the progress bar 636 provides an indication of the proximity…of the needle 170 relative to the target location 664”. As can be observed in Figure as 6-4, 6-5, & 6-6, the progress bar begins to fill in once the needle punctures the entry point and fills as it is advanced towards the target location. Therefore, Ayvali uses a first and second distance as is claimed, with the first distance representing the distance between the needle and the target and the second distance representing the distance between the entry point and the target.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Boctor and Dall such that the navigation view comprises a visualization of a fraction determined by dividing a first distance by a second distance or the second distance by the first distance, wherein the first distance is a distance between a position of the surgical instrument in the coordinate system and the target, and wherein the second distance is a distance between the recommended entry point and the target, wherein the visualization of the fraction is a progress bar, wherein the progress bar is concentrically formed around an alignment point in the navigation view, wherein the alignment point lies on a straight line between the recommended entry point and the planned target, as taught by Ayvali. Providing a visualization of the distance to the target from the entry point allows the operator to understand the necessary insertion depth to reach the target. Additionally, forming a progress bar concentrically around the alignment point in the navigation view allows the operator to monitor the distance to the target without taking their eyes off of the navigation view.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Boctor in view of Dall and Urquhart, as applied to claim 10, above, in further view of Ayvali.
Regarding claim 26, Boctor in view of Dall and Urquhart teach the method of claim 10, and Urquhart further teaches a second marker (plurality of rings or circles 129, [0084]) disposed relative to the center of the bullseye view to represent a trajectory of the surgical instrument relative to the straight line ([0084] & Figure 12).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Boctor and Dall to include a second marker disposed relative to the center of the bullseye view to represent a trajectory of the surgical instrument relative to the straight line, as taught by Urquhart. The second marker, represented by the plurality of rings or circles 129 in Urquhart, allows the correct trajectory of the surgical instrument to be intuitively visualized.
However, Boctor in view of Dall and Urquhart fail to disclose that the navigation view includes a first marker disposed relative to the center of the bullseye to represent a position of a distal tip of the surgical instrument relative to the recommended entry point.
Ayvali teaches that the navigation view includes a first marker (progress bar 636, [0127]) disposed relative to the center of the bullseye to represent a position of a distal tip of the surgical instrument relative to the recommended entry point ([0127] & Figures 6-4, 6-5, & 6-6).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Boctor, Dall, and Urquhart such that the navigation view includes a first marker disposed relative to the center of the bullseye to represent a position of a distal tip of the surgical instrument relative to the recommended entry point, as taught by Ayvali. Providing a visualization of the distance to the target from the entry point allows the operator to understand the necessary insertion depth to reach the target.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798