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, see pages 5-9, filed 28 August 2026, with respect to the rejection(s) of claim(s) 1-20 under 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of new prior art. Since, no amendment was made, the examiner wrote the rejection as non-final rejection.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over “Razzaque et al.,” US 2011/0137156 (hereinafter Razzaque).
Regarding to claim 1, Razzaque teaches a method, comprising:
tracking movement of a cautery tool (pose information is determined for a medical device, cauterizer [0077]a surgeon may want to track one or more a cauterizer, including electrocauterizer and Bovies [0114])
displaying a visualization of a pathway to be followed by the cautery tool (Figures 6A and 7 show displaying a visualization of a pathway to be followed, such as “projected path” that the needle will take, [0133]-[0134] Figure 3A-3B), the pathway corresponding to a plan for tissue resection with the cautery tool (projecting a cutting plane [0137]); and
updating the visualization based on the movement of the cautery tool (allow to watch as the needle advances through the tissue, image guidance system maintain the displayed ultrasound image within the needle’s path automatically [0180] Figure 23 and 36D, updating image with tracking [0227], [0244])
Razzaque teaches that tracking instrument for cutting and cutting plane can be displayed, and similar prediction information may be estimable or determinable for cauterizers ([0137]).
Razzaque also provides explicit example of needle tracking, Razzaque discloses that embodiments are used for many kinds of needle-based medical procedures, and the needle refer to any rigid needle like object such as electro-cautery device, Bovie ([0107]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify displaying needle advancement and cutting and cutting plane as taught by Razzaque to incorporate teaching of cauterizer, since tracking cauterizer was well known in the art as taught by Razzaque. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, implementing displaying cutting plane, trajectory and advancement of needle with cauterizers, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide information about procedures they are performing, the devices including cauterizers during the procedure, relative emplacements or poses of the device, prediction information (abstract) and there was reasonable expectation of success.
Regarding to claim 4, Razzaque teaches all limitations of claim 1 set forth above.
Razzaque further teaches following limitations:
Of claim 4, comprising resecting tissue along the pathway by the cautery tool (projected planes, cutting if the doctor were to advance the scalpel, which information can be also determined for cauterizers [0137]; visualization of a dissection tool relative to the fibroid in the image, and help physician cut the muscle wall down the midline of the fibroid or other desired cur approach [0231]; The examiner nots that [0231] discloses removing fibroids, while leaving the muscle wall, which is resection procedure).
Claims 2, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque as applied to claim 1 above, and further in view of “Quaid, III,” US 2010/0137882 (hereinafter Quaid, III).
Regarding to claim 2, Razzaque teaches all limitations of claim 1 as set forth above.
Razzaque does disclose tracking system with position sensing units ([0060]), sensing unit comprises optical trackers ([0065] optical tracker [0067]) but not further teach wherein tracking the movement of the cautery tool comprises optically tracking, by a stereo camera pair, a plurality of markers coupled to the cautery tool.
However, in the analogous field of endeavor in image guidance of medical instruments using optical tracking, Quaid, III teaches optically tracking instruments with markers, using a stereo camera pair ([0004] and [0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify tracking as taught by Razzaque to incorporate teaching of Quaid, III, since optical tracking using a stereo camera pair was well known in the art as taught by Quaid, III. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, using stereo camera pair for optical tracking of markers, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide optical tracking of area of interest and sensitive to infrared radiation ([0039]), and there was reasonable expectation of success.
Regarding to claim 7, Razzaque teaches all limitations of claim 1 as set forth above.
Razzaque does not further teach wherein displaying the pathway comprises displaying a model of an anatomical structure of a patient and displaying the pathway relative to the model.
However, in the analogous field of endeavor in image guided navigation of medical procedures, Quaid, III teaches a computer aided surgery that guide an instrument using 3-D model of anatomical features, with position and orientation of trajectories and manipulating position and/or orientation of resections ([0061], virtual pathway guides tool from an initial position toward a target area and a desired pose relative to anatomy of the patient, guiding surgical tool to the target area along a path or trajectory [0074]; [0110]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify image as taught by Razzaque to incorporate teaching of Quaid, III, since model of anatomical feature was well known in the art as taught by Quaid, III. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, reconstructing three-dimensional image models of anatomical features and displaying instrument relative to the anatomical feature, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide three dimensional position of instrument relative to the anatomy ([0110]), and there was reasonable expectation of success.
Regarding to claim 9, Razzaque and Quaid, III together teach all limitations of claim 7 as set forth above.
Quaid, III further teaches further comprising displaying a position of the cautery tool relative to the pathway ( guiding surgical tool to the target area along a path or trajectory [0074]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Razzaque as applied to claim 1 above, and further in view of “Quaid, III,” US 2010/0137882 (hereinafter Quaid, III) and “Conte et al.,” US 2007/0293869 (hereinafter Conte).
Regarding to claim 3, Razzaque teaches all limitations of claim 1 as set forth above.
Razzaque discloses optical tracking of cautery tool, but does not further teach wherein tracking the movement of the cautery tool comprises optically tracking, by a stereo camera pair, modular attachment coupled to the cautery tool.
However, in the analogous field of endeavor in image guidance of medical instruments, Quaid, III teaches optically tracking instruments with Razzaque’s, using a stereo camera pair ([0004] and [0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify tracking as taught by Razzaque to incorporate teaching of Quaid, III, since optical tracking using a stereo camera pair was well known in the art as taught by Quaid, III. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, using stereo camera pair for optical tracking of markers, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide optical tracking of area of interest and sensitive to infrared radiation ([0039]), and there was reasonable expectation of success.
Razzaque and Quaid, III do not explicitly disclose tracking a modular attachment coupled to the tool.
However, in the analogous field of endeavor in optically tracking instruments, Conte teaches a modular alignment system attached to the body of the instrument for optical tracker ([0014] and [0030]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify optical marker as taught by Quaid, III to incorporate teaching of Conte, since modular attachment of marker to the instrument was well known in the art as taught by Conte. One of ordinary skill in the art could have combined the elements as claimed by Razzaque and Quaid, III with no change in their respective functions, configuring module for attaching optical tracker to the instrument for tracking, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide properly positioning optical tracker ([0014]), and there was reasonable expectation of success.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque as applied to claims 1 and 4 above, and further in view of “Hamel,” US 2005/0251228 (hereinafter Hamel).
Regarding to claims 5- 6, Razzaque teaches all limitations of claims 1 and 4 as set forth above.
Razzaque does not further disclose following limitations:
Of claim 5, comprising activating, by the cautery tool, in response to manipulation of an activation button of the cautery tool.
Of claim 6, wherein the cautery tool is an electrocautery device.
However, in the analogous field of endeavor in cautery tool, Hamel teaches a cauterization device comprising following limitations:
Of claim 5, comprising activating, by the cautery tool, in response to manipulation of an activation button of the cautery tool (button activating cautery unit [0065] and [0070]).
Of claim 6, wherein the cautery tool is an electrocautery device (electrocautery tool [0025]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify cautery tool as taught by Razzaque to incorporate teaching of Hamel, since electrocautery device with activation button was well known in the art as taught by Hamel. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, configuring the cautery device to be electrocautery with activation button, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide electrically activated cautery unit and providing means to activate, adjust various modes and settings of the tools ([0004] and [0065]), and there was reasonable expectation of success.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Razzaque as applied to claim 7 above, and further in view of “Chabanas et al,” US 2013/0096373 (hereinafter Chabanas).
Regarding to claim 8, Razzaque and Quaid, III together teach all limitations of claim 7 as set forth above.
Razzaque and Quaid, III do not further teach updating a visualization of the model based on completed stages of the tissue resection by the cautery tool.
However, in the analogous field of endeavor in anatomical model for guiding procedures, Chabanas teaches constructing anatomical model ([0066]) and updating a visualization of the model based on completed stages of the tissue resection by the cautery tool (Figure 12, displaying real time image and virtual image for guiding resection, and until both images are similar, which implies that resecting takes place since virtual image is colored for region that to be achieved after resection, [0072]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify cautery tool as taught by Razzaque to incorporate teaching of Chabanas, since both are directed to cauterization device and image guidance of the resection, and updating a visualization of resected tissue during procedure to achieve after resection was well known in the art as taught by Chabanas. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, configuring its display to update until the after resection stage is acheived, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide visual guidance of resection steps until optimal result ([0072]), and there was reasonable expectation of success.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque as applied to claim 1 above, and further in view of “Giordano et al,” US 2006/0257379 (hereinafter Giordano).
Regarding to claim 10-11, Razzaque teaches all limitations of claim 1 as set forth above.
Razzaque does not further teaches controlling power to the cautery tool by comparing the movement of the cautery tool to the pathway.
However, in the analogous field of endeavor in guiding instrument during medical procedure, Giordano teaches navigating a movement of a cutting tool ([0079]), controlling power to the tool by comparing the movement of the tool to the pathway, wherein controlling the power to the cautery tool by comparing the movement of the cautery tool to the pathway comprises ceasing power to the cautery tool in response to a position of the cautery tool deviating from the pathway by greater than a threshold amount (electrically operable tool, a supply of energy to the cutting tool can be interrupted immediately, thus cutting process can be stopped if the actual cutting path deviates from the desired contour (comparison has to be performed to determine deviation occurred) [0080]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify navigating tool as taught by Razzaque to incorporate teaching of Giordano, since controlling power to the tool based on the positional deviation from the trajectory was well known in the art as taught by Giordano. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, configuring and programming to control the power to the tool based on a positional relationship to desired path, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide control of power to the tool based on the positional deviation from desired path ([0080]), and there was reasonable expectation of success.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Razzaque as applied to claim 1 above, and further in view of “Kimura et al,” US 2011/0196202 (hereinafter Kimura).
Regarding to claim 12, Razzaque teaches all limitations of claim 1 as set forth above.
Razzaque does not displaying an upcoming portion of the pathway in a flashing or pulsing manner.
However, in the analogous field of endeavor in guiding instruments, Kimura teaches the trajectory information of a section from the current position to the target position of the device with flashing or display color changing on a display ([0107]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify displaying planned path/trajectory as taught by Razzaque to incorporate teaching of Kimura, since flashing or display color changing on a display was well known in the art as taught by Kimura. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, configuring to display portion of the trajectory to be flashing manner, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to visually presenting trajectory information to user ([0107]), and there was reasonable expectation of success.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over “Razzaque et al.,” US 2011/0137156 (hereinafter Razzaque) and “Zhao et al.,” US 2009/0088634 (hereinafter Zhao).
Regarding to claim 13, Razzaque teaches a system, comprising:
a cautery tool (cauterizer [0062]);
a tracking system configured to track movement of the cautery tool (tracking movement of the surgical devices [0070], tracking a cauterizer [0114])
a display (display images [0123]); and
cause the display screen to display a visualization of a pathway to be followed by the cautery tool, the pathway corresponding to a plan for tissue resection with the cautery tool (a cauterizer tracked as part of an image guidance system, displaying cauterization volume and path [0131], projected path of the needle [0133], ); and
update the visualization based on the movement of the cautery tool (Real-time live intraoperative data, updating the image with tracking, imaging [0227], tool tracked and real-time emplacement shown relative to image [0244]).
Razzaque teaches that tracking instrument for cutting and cutting plane can be displayed, and similar prediction information may be estimable or determinable for cauterizers ([0137]).
Razzaque also provides explicit example of needle tracking, Razzaque discloses that embodiments are used for many kinds of needle-based medical procedures, and the needle refer to any rigid needle like object such as electro-cautery device, Bovie ([0107]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify displaying needle advancement and cutting and cutting plane as taught by Razzaque to incorporate teaching of cauterizer, since tracking cauterizer was well known in the art as taught by Razzaque. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, implementing displaying cutting plane, trajectory and advancement of needle with cauterizers, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide information about procedures they are performing, the devices including cauterizers during the procedure, relative emplacements or poses of the device, prediction information (abstract) and there was reasonable expectation of success.
Razzaque does not explicitly teach a display screen and a control system programmed to perform the limitations set forth above.
However, in the analogous field of endeavor in tracking tool, Zhao teaches tool tracking wherein a control console include the computer for controlling and displaying instruments in the surgical sites in a display screen ([0052], [0213], and [0215]; [0219]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify displaying and updating visualization as taught by Razzaque to incorporate teaching of Zhao, since a display device and a control system programmed to perform the function was well known in the art as taught by Zhao. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, configuring displaying the image in a display device and a controller programmed to perform the functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to implement tool tracking in software and executed by a computer and the processor ([0219]), and there was reasonable expectation of success.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Razzaque and Zhao as applied to claim 13 above, and further in view of “Conte et al.,” US 2007/0293869 (hereinafter Conte).
Regarding to claim 14, Razzaque and Zhao together teach all limitations of claim 13 as set forth above.
Razzaque and Zhao do not further teach wherein the cautery tool comprises a modular attachment comprising markers trackable by the tracking system.
However, in the analogous field of endeavor in optically tracking instruments, Conte teaches a modular alignment system attached to the body of the instrument for optical tracker ([0014] and [0030]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify optical markers as taught by Razzaque and Zhao to incorporate teaching of Conte, since modular attachment of markers to the instrument was well known in the art as taught by Conte. One of ordinary skill in the art could have combined the elements as claimed by Razzaque and Zhao with no change in their respective functions, configuring module for attaching optical tracker to the instrument for tracking, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide properly positioning optical tracker ([0014]), and there was reasonable expectation of success.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Razzaque, Zhao, and Conte as applied to claim 14 above, and further in view of “Hamel,” US 2005/0251228 (hereinafter Hamel).
Regarding to claim 15, over Razzaque, Zhao, and Conte together teach all limitations of claim 14 as set forth above.
Razzaque does not further disclose wherein the cautery tool comprises an activation button, the cautery tool configured to activate in response to pressing of the activation button.
However, in the analogous field of endeavor in cautery tool, Hamel teaches a cauterization device comprising an activation button, the cautery tool configured to activate in response to pressing of the activation button (button activating cautery unit [0065] and [0070]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify cautery tool as taught by Razzaque to incorporate teaching of Hamel, since electrocautery device with activation button was well known in the art as taught by Hamel. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, configuring the cautery device to be electrocautery with activation button, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide electrically activated cautery unit and providing means to activate, adjust various modes and settings of the tools ([0004] and [0065]), and there was reasonable expectation of success.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque and Zhao as applied to claim 13 above, and further in view of “Giordano et al,” US 2006/0257379 (hereinafter Giordano).
Regarding to claim 16-17, Razzaque and Zhao together teach all limitations of claim 13 as set forth above.
Razzaque does not further teach controlling power to the cautery tool by comparing the movement of the cautery tool to the pathway.
However, in the analogous field of endeavor in guiding instrument during medical procedure, Giordano teaches navigating a movement of a cutting tool ([0079]), controlling power to the tool by comparing the movement of the tool to the pathway, wherein controlling the power to the cautery tool by comparing the movement of the cautery tool to the pathway comprises ceasing power to the cautery tool in response to a position of the cautery tool deviating from the pathway by greater than a threshold amount (electrically operable tool, a supply of energy to the cutting tool can be interrupted immediately, thus cutting process can be stopped if the actual cutting path deviates from the desired contour (comparison has to be performed to determine deviation occurred) [0080]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify navigating tool as taught by Razzaque to incorporate teaching of Giordano, since controlling power to the tool based on the positional deviation from the trajectory was well known in the art as taught by Giordano. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, configuring and programming to control the power to the tool based on a positional relationship to desired path, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide control of power to the tool based on the positional deviation from desired path ([0080]), and there was reasonable expectation of success.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque and Zhao as applied to claim 13 above, and further in view of “Kimura et al,” US 2011/0196202 (hereinafter Kimura).
Regarding to claims 18-19, Razzaque and Zhao together teach all limitations of claim 13 as set forth above.
Razzaque and Zhao do not disclose displaying an upcoming portion of the pathway visually distinguished from another portion of the pathway and by a flashing or pulsing manner.
However, in the analogous field of endeavor in guiding instruments, Kimura teaches the trajectory information of a section from the current position to the target position of the device with flashing or display color changing on a display ([0107]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify displaying planned path/trajectory as taught by Razzaque to incorporate teaching of Kimura, since flashing or display color changing on a display was well known in the art as taught by Kimura. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, configuring to display portion of the trajectory to be flashing manner, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to visually presenting trajectory information to user ([0107]), and there was reasonable expectation of success.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Razzaque and Zhao as applied to claim 13 above, and further in view of “Quaid, III et al,” US 2010/0137882 (hereinafter Quaid, III).
Regarding to claim 20, Razzaque and Zhao together teach all limitations of claim 13 as set forth above.
Razzaque further teaches performing a medical procedure through the bone ([0008]), and using cautery tool ([0140] and [0159]).
Razzaque does not further teach visualization of the pathway relative to a model and a representation of the tool.
However, in the analogous field of endeavor in image guided navigation of medical procedures, Quaid, III teaches a computer aided surgery that guide an instrument using 3-D model of anatomical features, with position and orientation of trajectories and manipulating position and/or orientation of resections ([0061], virtual pathway guides tool from an initial position toward a target area and a desired pose relative to anatomy of the patient, guiding surgical tool to the target area along a path or trajectory [0074]; [0110]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify image as taught by Razzaque to incorporate teaching of Quaid, III, since model of anatomical feature was well known in the art as taught by Quaid, III. One of ordinary skill in the art could have combined the elements as claimed by Razzaque with no change in their respective functions, reconstructing three-dimensional image models of anatomical features and displaying instrument relative to the anatomical feature, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide three dimensional position of instrument relative to the anatomy ([0110]), and there was reasonable expectation of success.
Conclusion
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
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