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 Amendment
This action is in response to the amendments and remarks filed on 09/05/2025. The amendments filed on 09/05/2025 have been entered. Accordingly Claims 16-30 are pending. The previous objections and rejections of claims 16-30 have been withdrawn in light of Applicant’s amendments and remarks in the claim set filed 09/05/2025.
Claim Objections
Claim 28, is objected to because of the following informalities: limitation “…internal referential.” Is recommended to be recited as “…internal referential[[.]];”
Claim 22, is objected to because of the following informalities: “…presents a size comprised between…” is recommended to be recited as “…[[presents]] is a size [[comprised]] between…”.
Appropriate corrections are required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the claim 16 limitation “…wherein the control unit is further designed to display, on the screen, the at least one stored ultrasound image and to display, in real time, the localization of the micro-device on said at least one ultrasound image.”, claim 28 limitation “… the visualization, on a screen, of an ultrasound image of a target body part of a patient, the ultrasound image being aligned with the internal referential, the real time display, on the screen, within the displayed ultrasound image of said micro device localization.” and claim 30 limitations “wherein the ultrasound image is used to: plan at least one micro-device path, monitor, in real time, the micro-device path following, determine, in real time, if an obstacle is situated on the planned path, plan, if necessary, a new micro-device path in order to avoid said obstacle.”, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 28-30 are 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 28 recites the limitations "…the tracking system" in line 2, “…with a securing body part of the patient…”, lines 5-6 and “…at least partially the target body part…”, in line 6. There is insufficient antecedent basis for these limitations in the claim.
Regarding Claim 30, limitation “…determine, if necessary, a new micro-device path in order to avoids said obstacle” is a conditional limitation that is unclear whether the limitations following the “if” phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 16-17, 19-29 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (U.S. 20200281661, September 10, 2020)(hereinafter, “Govari”) in view of Vesely et. al. (U.S. 6246898, June 12, 2001)(hereinafter, “Vesely”) and Govari et. al. (U.S. 20080125646, May 29, 2008)(hereinafter, “Govari’08).
Regarding Claim 16, Govari teaches: A micro-device tracking and visualization system configured to monitor a target body part of a patient and localizing a micro-device inside said target body part (Fig. 1A, catheter-based cerebrovascular tracking system, [0048]), the tracking system comprising:
a micro-device designed to be remotely steered and controlled from outside the target body part (Fig. 1A, element 28, brain catheter, “Physician 54, operating system 20a, holds a brain catheter controller handle 29, which is connected to the proximal end of brain catheter 28. Controller handle 29 allows the physician 54 to advance and navigate brain catheter 28 in the brain, for example, through an entry point 22 at an artery at a thigh of patient 32.” [0051]. See reproduced Fig 1A below),
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a control unit comprising a memory, the memory being configured to store at least one ultrasound image of the target body part (“Processing circuitry 40 uses software stored in the memory 42 to operate system 20a. In practice, some or all of the functions of the processing circuitry 40 may be combined in a single physical component or, alternatively, implemented using multiple physical components.” [0053]; “The processing circuitry 40 is configured to render (block 142) to the display 56 (FIG. 1) the image 108 (FIGS. 9-11) of at least part of the brain of the living subject with the representation 100 of a length of the shaft of the brain catheter 28 in at least one blood vessel of the blood vessels 76 (FIGS. 5-11) of the brain with respective positions along the length of the shaft being located in the image 108 responsively to respective ones of the tracked locations from the movement log 98, which has been amended to add one or more tracked locations and optionally amended to remove one or more tracked locations as described in the step of block 134.” [0091]),
at least one probe configured to be brought in contact with the patient (“…the tracking subsystem 33 may be an electrically-based tracking subsystem using multiple head surface electrodes…to track the position of the brain catheter 28 based on a signal emitted by at least one electrode (comprised in the location tracking transducer) of the brain catheter 28. The tracking subsystem 33 may be implemented using any suitable location tracking subsystem, for example, but not limited to, an ultrasound-based tracking system where the location tracking transducer includes at least one ultrasound transducer. Using tracking subsystem 33, a physician 54 advances the distal end of the brain catheter 28 through blood vessels…” [0049]),
at least one tracker configured to be connected to the micro-device (“The position of the distal end of the brain catheter 28 may be tracked using a tracking subsystem 33, which tracks position and orientation coordinates of a location tracking transducer fitted at the distal end. The location tracking transducer is configured to output a signal that is indicative of a location of the transducer in the body-part (e.g. the brain). This signal is processed by the tracking subsystem 33 to track the locations of the distal end of the brain catheter 28 over time…” [0049]),
at least a screen (“The processing circuitry 40 uses the images to present, for example, a brain section image 59 on a display 56.” [0049]),
wherein the at least one probe and the at least one tracker communicate by means of ultrasound technology, the control unit being thus able to localize, in real time, the at least one tracker inside the target body part within an internal referential defined with regards to the at least one probe (“…the tracking subsystem 33 may be an electrically-based tracking subsystem using multiple head surface electrodes…to track the position of the brain catheter 28 based on a signal emitted by at least one electrode (comprised in the location tracking transducer) of the brain catheter 28. The tracking subsystem 33 may be implemented using any suitable location tracking subsystem…an ultrasound-based tracking system where the location tracking transducer includes at least one ultrasound transducer. Using tracking subsystem 33, a physician 54 advances the distal end of the brain catheter 28 through blood vessels…” [0049]; “…physician 54 navigates the distal end of brain catheter 28 with the aid of real-time images rendered based on position and orientation signals from the location tracking transducer fitted at the distal end of brain catheter 28.” [0051]),
wherein the control unit is further designed to display, on the screen, the at least one ultrasound image stored inside the memory of the control unit, and to display, in real time, the localization of the micro-device on said at least one ultrasound image (“The processing circuitry 40 uses the images to present, for example, a brain section image 59 on a display 56.” [0049]; “Console 50 receives the position signals via a cable 19 that connects to brain catheter 28 via handle 29.” [0051]; “The processing circuitry 40 is configured to render (block 142) to the display 56 (FIG. 1) the image 108 (FIGS. 9-11) of at least part of the brain of the living subject with the representation 100 of a length of the shaft of the brain catheter 28 in at least one blood vessel of the blood vessels 76 (FIGS. 5-11) of the brain with respective positions along the length of the shaft being located in the image 108 responsively to respective ones of the tracked locations from the movement log 98, which has been amended to add one or more tracked locations and optionally amended to remove one or more tracked locations as described in the step of block 134.” [0091]);
wherein the ultrasound tracking of the tracker is co-registered with an acquisition of the at least one ultrasound image acquisition within the internal referential (“…during the disclosed catheterization, systems 20a and 20b register a position of a distal end of a brain catheter 28 inside the patient's brain, with frames of reference of brain images of the patient 32. The position of the brain catheter 28 may be tracked using a tracking subsystem 33, which tracks position and orientation coordinates of a location tracking transducer fitted at the distal end. The location tracking transducer is configured to output a signal that is indicative of a location of the transducer in the body-part…” [0049]).
Govari does not teach the micro-device being steered and controlled in a contactless manner; a securing body part of the probe where the securing part surrounds at least partially the target body part.
Vesely in the field of instrument tracking and imaging systems teaches a 3D tracking system where a plurality of ultrasonic transducers are mounted on various positions of a cap that is mounted to the head of an individual, see Fig. 20 (column 34, lines 13-34).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the probe of Govari to include a securing body part where the securing part surrounds at least partially the target body part as taught in Vesely to mount and secure the transducer(s) to the head for effective transmission/receiving through the head and target(s).
The combination of references does not teach the micro-device being steered and controlled in a contactless manner.
Govari’08 in the field of tracking-based systems teaches: “FIG. 1 is a schematic, pictorial illustration of a system 20 for position tracking and steering of intrabody objects…” [0030]; “System 20 can be used for performing a variety of intra-cardiac surgical and diagnostic procedures in which navigation and steering of the catheter is performed automatically or semi-automatically by the system, and not manually by the physician.” [0031].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the micro-device in the combination of references to be steered and controlled in a contactless manner as taught in Govari’08 for automatic or semi-automatic performance of various intra-surgical and diagnostic procedures (Govari’08, [0031]).
Regarding Claim 17, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
Govari further teaches: wherein the at least one ultrasound image is acquired by means of the at least one probe (“…the tracking subsystem 33 may be an electrically-based tracking subsystem using multiple head surface electrodes…to track the position of the brain catheter 28 based on a signal emitted by at least one electrode (comprised in the location tracking transducer) of the brain catheter 28. The tracking subsystem 33 may be implemented using any suitable location tracking subsystem, for example, but not limited to, an ultrasound-based tracking system where the location tracking transducer includes at least one ultrasound transducer. Using tracking subsystem 33, a physician 54 advances the distal end of the brain catheter 28 through blood vessels…” [0049]).
Regarding Claim 19, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
Govari further teaches: wherein the at least one probe comprises at least one transducer and the at least one tracker comprises at least one ultrasound sensor (“…the tracking subsystem 33 may be an electrically-based tracking subsystem using multiple head surface electrodes…to track the position of the brain catheter 28 based on a signal emitted by at least one electrode (comprised in the location tracking transducer) of the brain catheter 28. The tracking subsystem 33 may be implemented using any suitable location tracking subsystem, for example, but not limited to, an ultrasound-based tracking system where the location tracking transducer includes at least one ultrasound transducer. Using tracking subsystem 33, a physician 54 advances the distal end of the brain catheter 28 through blood vessels…” [0049]).
Govari is silent with respect to the transducer electrodes being ultrasound.
Vesely in the field of instrument tracking and imaging systems teaches a 3D tracking system where a plurality of ultrasonic transducers are mounted on various positions of a cap that is mounted to the head of an individual, see Fig. 20 (column 34, lines 13-34).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the transducer electrodes in Govari to being ultrasound in Vesely for relative ease of usage and abilities to visualize blood flow and brain activity.
Regarding Claim 20, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
Govari further teaches: wherein the at least one probe comprises at least one ultrasound sensor and the at least one tracker comprises at least one ultrasound transducer (“…the tracking subsystem 33 may be an electrically-based tracking subsystem using multiple head surface electrodes…to track the position of the brain catheter 28 based on a signal emitted by at least one electrode (comprised in the location tracking transducer) of the brain catheter 28. The tracking subsystem 33 may be implemented using any suitable location tracking subsystem, for example, but not limited to, an ultrasound-based tracking system where the location tracking transducer includes at least one ultrasound transducer. Using tracking subsystem 33, a physician 54 advances the distal end of the brain catheter 28 through blood vessels…” [0049]; “…further compensation of head motion is provided by attaching a reference sensor 21 to the patient's forehead. Console 50 is configured to receive signals from reference sensor 21 via a cable 27.” [0050]).
Regarding Claim 21, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
Govari does not teach: wherein the at least one tracker comprises a piezo-electric transducer.
Vesely in the field of instrument tracking and imaging systems teaches: “…the 3-D tracking and imaging system makes use of numerous piezoelectric (PZT or PVDF) ultrasonic transducers affixed to stable or moving locations on the patient or on devices inserted into the patient…” (column 32, lines 8-11).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the at least one tracker in the combination of references to comprise a piezo-electric transducer as taught in Vesely for high efficiency transmission (Vesely, column 18, line 55).
Regarding Claim 22, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
Govari further teaches: wherein the micro device presents a size comprised between 3micom and 3mm in diameter and up to 2cm in length (“…the catheter has a diameter of 1 mm or less...” [0012]).
Regarding Claim 23, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
Govari further teaches: wherein the localization of the micro-device reaches a precision better than half the size of a wavelength of the ultrasound used to perform the localization (“The position of the distal end of the brain catheter 28 may be tracked using a tracking subsystem 33, which tracks position and orientation coordinates of a location tracking transducer fitted at the distal end. The location tracking transducer is configured to output a signal that is indicative of a location of the transducer in the body-part (e.g. the brain). This signal is processed by the tracking subsystem 33 to track the locations of the distal end of the brain catheter 28 over time…” [0049]),
Regarding Claim 24, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
With respect to limitations: wherein the memory of the control unit is configured to store a succession of at least ones ultrasound images of the target body structure, each new at least one ultrasound image replacing the prior one, Govari further teaches: “…the rendering includes rendering the length of the shaft so that the respective positions along the length of the shaft are located in the image responsively to the respective tracked locations a temporal order of the tracked locations in the movement log with one of the positions of the length of the shaft closest to a distal tip of the catheter corresponding with a most recent one of the tracked locations in the movement log.” [0015]; “Controller handle 29 allows the physician 54 to advance and navigate brain catheter 28 in the brain, for example, through an entry point 22 at an artery at a thigh of patient 32. As noted above and described below, physician 54 navigates the distal end of brain catheter 28 with the aid of real-time images rendered based on position and orientation signals from the location tracking transducer fitted at the distal end of brain catheter 28.” [0051].Since the images rendered are continuously updated with an image of the area being viewed and the positioning information of the catheter, this is being interpreted as replacement of the previous.
Regarding Claim 25, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
With respect to limitations: wherein an ultrasound image acquisition is done in real time, a new ultrasound image acquisition being launched as soon the prior ultrasound image acquisition is terminated, each new ultrasound image replacing the prior one as soon its acquisition is terminated, Govari further teaches: “…the rendering includes rendering the length of the shaft so that the respective positions along the length of the shaft are located in the image responsively to the respective tracked locations a temporal order of the tracked locations in the movement log with one of the positions of the length of the shaft closest to a distal tip of the catheter corresponding with a most recent one of the tracked locations in the movement log.” [0015]; “Controller handle 29 allows the physician 54 to advance and navigate brain catheter 28 in the brain, for example, through an entry point 22 at an artery at a thigh of patient 32. As noted above and described below, physician 54 navigates the distal end of brain catheter 28 with the aid of real-time images rendered based on position and orientation signals from the location tracking transducer fitted at the distal end of brain catheter 28.” [0051].Since the images rendered are continuously updated with an image of the area being viewed and the positioning information of the catheter, this is being interpreted as replacement of the previous and termination is the ending of the current viewing before physician moves the catheter to the subsequent position.
Regarding Claim 26, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
Govari further teaches: wherein the target body part is the patient's brain (Fig. 1A, element 28, brain catheter, “Physician 54, operating system 20a, holds a brain catheter controller handle 29, which is connected to the proximal end of brain catheter 28. Controller handle 29 allows the physician 54 to advance and navigate brain catheter 28 in the brain, for example, through an entry point 22 at an artery at a thigh of patient 32.” [0051]. See reproduced Fig 1A below).
Regarding Claim 27, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
Govari does not explicitly teach: wherein the micro-device is designed to drop at least one contrast agent inside the target body part, the control unit being able to localize and display, on the ultrasound image, said at least one contrast agent.
Vesely in the field of instrument tracking and imaging systems teaches: “...contrast agents are frequently injected into patients during catheter procedures. These injections can provide further information on the actual location of the catheter and help physicians to plan subsequent catheter movements.” (column 9, lines 36-38); “The catheter is then used to inject a sealant, such as glue (e.g., n-butyl-cyanoacrylate) mixed with a contrast agent, that hardens and embolizes, and then plugs up the micro artery down stream.” (column 9, lines 61-64).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the micro-device in Govari to be designed to drop at least one contrast agent inside the target body part as taught in Vesely for the intended purpose to localize and display, on the ultrasound image, said at least one contrast agent as “These injections can provide further information on the actual location of the catheter and help physicians to plan subsequent catheter movements.” (Vesely, column 9, lines 36-38).
Regarding Claim 28, Govari teaches: A micro-device tracking and localization method implemented by means of the tracking system comprising (Fig. 1A, catheter-based cerebrovascular tracking system, [0048]):
a micro-device designed to be remotely steered and controlled from outside the target body part (Fig. 1A, element 28, brain catheter, “Physician 54, operating system 20a, holds a brain catheter controller handle 29, which is connected to the proximal end of brain catheter 28. Controller handle 29 allows the physician 54 to advance and navigate brain catheter 28 in the brain, for example, through an entry point 22 at an artery at a thigh of patient 32.” [0051]. See reproduced Fig 1A above),
at least one probe configured to be brought in contact with the patient (“…the tracking subsystem 33 may be an electrically-based tracking subsystem using multiple head surface electrodes…to track the position of the brain catheter 28 based on a signal emitted by at least one electrode (comprised in the location tracking transducer) of the brain catheter 28. The tracking subsystem 33 may be implemented using any suitable location tracking subsystem, for example, but not limited to, an ultrasound-based tracking system where the location tracking transducer includes at least one ultrasound transducer. Using tracking subsystem 33, a physician 54 advances the distal end of the brain catheter 28 through blood vessels…” [0049]),
a control unit comprising a memory, the memory being configured to store at least one ultrasound image of the target body part (“Processing circuitry 40 uses software stored in the memory 42 to operate system 20a. In practice, some or all of the functions of the processing circuitry 40 may be combined in a single physical component or, alternatively, implemented using multiple physical components.” [0053]; “The processing circuitry 40 is configured to render (block 142) to the display 56 (FIG. 1) the image 108 (FIGS. 9-11) of at least part of the brain of the living subject with the representation 100 of a length of the shaft of the brain catheter 28 in at least one blood vessel of the blood vessels 76 (FIGS. 5-11) of the brain with respective positions along the length of the shaft being located in the image 108 responsively to respective ones of the tracked locations from the movement log 98, which has been amended to add one or more tracked locations and optionally amended to remove one or more tracked locations as described in the step of block 134.” [0091]),
at least one tracker configured to be connected to the micro-device (“The position of the distal end of the brain catheter 28 may be tracked using a tracking subsystem 33, which tracks position and orientation coordinates of a location tracking transducer fitted at the distal end. The location tracking transducer is configured to output a signal that is indicative of a location of the transducer in the body-part (e.g. the brain). This signal is processed by the tracking subsystem 33 to track the locations of the distal end of the brain catheter 28 over time…” [0049]),
at least a screen (“The processing circuitry 40 uses the images to present, for example, a brain section image 59 on a display 56.” [0049]),
wherein the at least one probe and the at least one tracker communicate by means of ultrasound technology, the control unit being thus able to localize, in real time, the at least one tracker inside the target body part within an internal referential defined with regards to the at least one probe (“…the tracking subsystem 33 may be an electrically-based tracking subsystem using multiple head surface electrodes…to track the position of the brain catheter 28 based on a signal emitted by at least one electrode (comprised in the location tracking transducer) of the brain catheter 28. The tracking subsystem 33 may be implemented using any suitable location tracking subsystem…an ultrasound-based tracking system where the location tracking transducer includes at least one ultrasound transducer. Using tracking subsystem 33, a physician 54 advances the distal end of the brain catheter 28 through blood vessels…” [0049]; “…physician 54 navigates the distal end of brain catheter 28 with the aid of real-time images rendered based on position and orientation signals from the location tracking transducer fitted at the distal end of brain catheter 28.” [0051]),
wherein the control unit is further designed to display, on the screen, the at least one ultrasound image stored inside the memory of the control unit, and to display, in real time, the localization of the micro-device on said at least one ultrasound image (“The processing circuitry 40 uses the images to present, for example, a brain section image 59 on a display 56.” [0049]; “Console 50 receives the position signals via a cable 19 that connects to brain catheter 28 via handle 29.” [0051]; “The processing circuitry 40 is configured to render (block 142) to the display 56 (FIG. 1) the image 108 (FIGS. 9-11) of at least part of the brain of the living subject with the representation 100 of a length of the shaft of the brain catheter 28 in at least one blood vessel of the blood vessels 76 (FIGS. 5-11) of the brain with respective positions along the length of the shaft being located in the image 108 responsively to respective ones of the tracked locations from the movement log 98, which has been amended to add one or more tracked locations and optionally amended to remove one or more tracked locations as described in the step of block 134.” [0091]);
wherein the ultrasound tracking of the tracker is co-registered with an acquisition of the at least one ultrasound image acquisition within the internal referential (“…during the disclosed catheterization, systems 20a and 20b register a position of a distal end of a brain catheter 28 inside the patient's brain, with frames of reference of brain images of the patient 32. The position of the brain catheter 28 may be tracked using a tracking subsystem 33, which tracks position and orientation coordinates of a location tracking transducer fitted at the distal end. The location tracking transducer is configured to output a signal that is indicative of a location of the transducer in the body-part…” [0049]);
wherein the method enables, at the same time: the real time tracking of the micro-device, the real time localization of the micro-device within the internal referential (Fig. 1A, element 28, brain catheter, “Physician 54, operating system 20a, holds a brain catheter controller handle 29, which is connected to the proximal end of brain catheter 28. Controller handle 29 allows the physician 54 to advance and navigate brain catheter 28 in the brain, for example, through an entry point 22 at an artery at a thigh of patient 32.” [0051]. See reproduced Fig 1A below),
the real time localization of said micro-device inside the target body structure, the method further enables, at the same time: the visualization, on a screen, of an ultrasound image of a target body part of a patient, the ultrasound image being aligned with the internal referential, the real time display, on the screen, within the displayed ultrasound image of said micro device localization (“…the rendering includes rendering the length of the shaft so that the respective positions along the length of the shaft are located in the image responsively to the respective tracked locations a temporal order of the tracked locations in the movement log with one of the positions of the length of the shaft closest to a distal tip of the catheter corresponding with a most recent one of the tracked locations in the movement log.” [0015]; “Controller handle 29 allows the physician 54 to advance and navigate brain catheter 28 in the brain, for example, through an entry point 22 at an artery at a thigh of patient 32. As noted above and described below, physician 54 navigates the distal end of brain catheter 28 with the aid of real-time images rendered based on position and orientation signals from the location tracking transducer fitted at the distal end of brain catheter 28.” [0051]; “Console 50 receives the position signals via a cable 19 that connects to brain catheter 28 via handle 29.” [0051]; “The processing circuitry 40 is configured to render (block 142) to the display 56 (FIG. 1) the image 108 (FIGS. 9-11) of at least part of the brain of the living subject with the representation 100 of a length of the shaft of the brain catheter 28 in at least one blood vessel of the blood vessels 76 (FIGS. 5-11) of the brain with respective positions along the length of the shaft being located in the image 108 responsively to respective ones of the tracked locations from the movement log 98, which has been amended to add one or more tracked locations and optionally amended to remove one or more tracked locations as described in the step of block 134.” [0091]).
Govari does not teach the micro-device being steered and controlled in a contactless manner; a securing body part of the probe where the securing part surrounds at least partially the target body part.
Vesely in the field of instrument tracking and imaging systems teaches a 3D tracking system where a plurality of ultrasonic transducers are mounted on various positions of a cap that is mounted to the head of an individual, see Fig. 20 (column 34, lines 13-34).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the probe of Govari to include a securing body part where the securing part surrounds at least partially the target body part as taught in Vesely to mount and secure the transducer(s) to the head for effective transmission/receiving through the head and target(s).
The combination of references does not teach the micro-device being steered and controlled in a contactless manner.
Govari’08 in the field of tracking-based systems teaches: “FIG. 1 is a schematic, pictorial illustration of a system 20 for position tracking and steering of intrabody objects…” [0030]; “System 20 can be used for performing a variety of intra-cardiac surgical and diagnostic procedures in which navigation and steering of the catheter is performed automatically or semi-automatically by the system, and not manually by the physician.” [0031].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the micro-device in the combination of references to be steered and controlled in a contactless manner as taught in Govari’08 for automatic or semi-automatic performance of various intra-surgical and diagnostic procedures (Govari’08, [0031]).
Regarding Claim 29, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
Govari further teaches: wherein the at least one probe displays two working modes: an acquisition mode, during which the at least one probe acquires the ultrasound image, and a tracking mode during which the at least one probe communicates with the at least one tracker, the at least one probe is switched from the acquisition mode to the tracking mode at least one time (“An image of at least part of the brain of the living subject, based on a pre-registered image, is rendered to a display…” [0040]; “…the tracking subsystem 33 may be an electrically-based tracking subsystem using multiple head surface electrodes…to track the position of the brain catheter 28 based on a signal emitted by at least one electrode (comprised in the location tracking transducer) of the brain catheter 28. The tracking subsystem 33 may be implemented using any suitable location tracking subsystem, for example, but not limited to, an ultrasound-based tracking system where the location tracking transducer includes at least one ultrasound transducer. Using tracking subsystem 33, a physician 54 advances the distal end of the brain catheter 28 through blood vessels…” [0049]; “…further compensation of head motion is provided by attaching a reference sensor 21 to the patient's forehead. Console 50 is configured to receive signals from reference sensor 21 via a cable 27.” [0050]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Vesely and Govari’08 as applied to claim 17 above, and further in view of Errico et. al. (“Ultrafast ultrasound localization microscopy for deep super-resolution vascular imaging.” 2015)(hereinafter,“Errico”).
Regarding Claim 18, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
The combination of references does not teach: wherein the at least one ultrasound image is an ULM image.
Errico in the field of image-based systems teaches: “Here, we demonstrate ultrafast ultrasound localization microscopy (uULM), which combines deep penetration and super-resolution imaging at unprecedented spatiotemporal resolution, by using clinically approved contrast agents: inert gas microbubbles. uULM is implemented in vivo…”(pg. 499, column 2).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the at least one ultrasound image in the combination of references to be an ULM image as taught in Errico to allow “…reconstruction of entire organs within tens of seconds…” (Errico, pg. 500, column 1).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Vesely and Govari’08 as applied to claim 28 above, and further in view of Quaid et. al. (U.S. 20040106916, June 3, 2004)(hereinafter, “Quaid”).
Regarding Claim 30, the combination of Govari, Vesely and Govari’08 teach the claim limitations as noted above.
The combination of references does not teach: wherein the at least one ultrasound image is used to: plan at least one micro-device path, monitor, in real time, the micro-device path following, determine, in real time, if an obstacle is situated on the planned path, plan, if needed, a new micro-device path in order to avoid said obstacle.
Quaid in the field of image guided systems teaches: “FIG. 3C is a flowchart of an exemplary method 140 for intra-operative haptic planning of a surgical procedure.” [0064]; “In step 146, anatomical obstacles to be avoided are defined. The anatomical obstacles comprise features to be avoided during surgery, such as major blood vessels, tendons, nerves, critical areas of the brain, organs, healthy bones or other tissues, and/or the like.” [0066]; “In step 152, a determination is made as to whether the virtual tool is intersecting any anatomical obstacles. If the virtual tool is not intersecting any anatomical obstacles, then the process starting at step 162 is executed. Otherwise, the process starting at step 154 is executed. In step 154, haptic cues are provided by haptic device 113 to the user.” [0068]; “In step 158, haptic device 113 is moved, preferably by the surgeon. Haptic device 113 is preferably moved based at least in part on the haptic cues provided by haptic device 113 to the surgeon. The position of surgical tool 112 had it been coupled to haptic device 113 is tracked by the virtual tool and displayed on display device 30. Preferably, the user moves haptic device 113 until an equilibrium pose is found. In the equilibrium position, the cues created by the attractive haptic objects are active and those created by the repulsive haptic objects are inactive.” [0070].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that wherein the ultrasound image is used to: plan at least one micro-device path, monitor, in real time, the micro-device path following, determine, in real time, if an obstacle is situated on the planned path, plan, if needed, a new micro-device path in order to avoid said obstacle as taught in Quaid to “…provides for tighter coupling of the planning and execution phases of the surgical procedure. Planning for the surgical procedure is preferably performed intra-operatively with respect to the patient.” (Quaid, [0074]).
Response to Arguments
With regards to Applicant’s remarks regarding Objections to the Drawings: “…In response to the objection to the Drawings, the claims are amended to address the drawing objections.”, Examiner respectfully disagrees the amendments to the claims address the objections raised with respect to the drawings. The claim amendments clarified or overcame formalities and 112(b) issues risen in the previous office action. The amendments are not sufficient for the drawing objections and as such Examiner respectfully, maintains the objections.
In response to Applicant’s remarks against references Govari and Vesely individually with respect to the points 1-5 identified in the remarks and more specifically with regards to limitation “…at least one probe configured to be brought in contact with a securing body part of the patient…”, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
With regards to Applicant’s arguments: “Regarding points (3) and (4), the technical equivalent of an internal referential disclosed by GOVARI is the location pad 24a. This location pad 24a is part of system 20a and is configured to generate a magnetic field in order to be able to position the patient's head in space (see for example paragraph [0050]). This magnetic system is not part of the tracking subsystem 33 and is not an ultrasound system. The probe as defined in the present invention does not have a technical equivalent in GOVARI. Regarding point (5), GOVARI remains completely silent about such a feature.”, Examiner respectfully disagrees with Applicant’s arguments. First the claims do not explicitly state the tracking system is ultrasound just that the probe and tracker “…communicate by means of ultrasound technology…” as recited in independent claims 16 and 28. Secondly, Applicant has utilized passages cited and not cited differently then what is provided in the office action above to provide an interpretation to Govari different than provided by Examiner. Applicant’s arguments also appear to a narrower interpretation of the recited limitations in claim 16.
With regards to Applicant’s remarks regarding amended claim 16 limitations are moot in view of the new grounds of rejections.
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.
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/AMAL ALY FARAG/ Primary Examiner, Art Unit 3798