DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/18/2026 has been entered.
Response to Amendment
The proposed reply filed on 02/19/2026 has been entered. Claims 1-2, 5-17, 19, and 21-22 are pending in the current application. The amendments to the claims have overcome the specification objections.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-12, and 15 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 15 recites the limitation “an electromagnetic-ultrasound transducer (EMUST) configured to emit both the EM signal and the US signal in response to detecting the EM field”. The specification fails to describe or define an EMUST configured to emit both EM and US signals in response to detecting EM field. Paragraphs 0140-0142 disclose : The EMUST may be activated by a magnetic field, as also discussed above. Activation or affecting the EMUST with a magnetic field may cause it to vibrate and emit an ultrasonic signal and/or emit or generate a field. Similarly, the EMUST may also receive an ultrasound signal and emit a magnetic or electromagnetic field that may be sensed. Thus, the EMUST may be an US transducer and an EM transducer. According to various embodiments, therefore, an EM navigation space may be co-related to a US navigation space and/or allow for transmission there between by having an EM transceiver 716 emit the EM field 718 that is received at the EMUST 710 and the EMUST 710 may transduce the EM field to an ultrasound signal 708 that is received at the US receiver. In a reverse manner, the US transceiver 704 may emit the US signal 706 that is received and sensed at the EMUST 710. The EMUST 710 may transduce the US signal to an EM field 720 that is sensed at the EM receiver 716. Thus, the specification describes that the EMUST emit US signals in response to detected EM field and emits EM signals in response to detected US signals. The examiner questions how does the EMUST emit both signals in response to detecting one trigger (EM field)? The specification fails to disclose how the EMUST is able to emit EM signals in response to detecting EM field.
The remaining claims are rejected based on their dependency.
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 1-2, 5-12, and 15 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 1 recites the limitation “an electromagnetic-ultrasound transducer (EMUST) configured to emit both the EM signal and the US signal in response to detecting the EM field” it is unclear how the EMUST transmits both EM and US signals in response to only EM field.
Claim 15 recites the limitation “wherein each EMUST is configured to emit both the respective EM signal and the respective US signal in response to detecting the EM field” it is unclear how the EMUST transmits both EM and US signals in response to only EM field.
Claims 2 and 5-12 are rejected based on their dependency.
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.
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.
Claim(s) 1-2, 5-17, 19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Snyder et al. (US 2020/0237445) in the view of Govari et al. (US 7,575,550).
Regarding claim 1, Snyder teaches a system for navigating a procedure, comprising (para. 0037; the navigation system):
an electromagnetic (EM) navigation system configured to emit an EM field, and to determine a pose of an EM tracking device in response to detecting an EM signal (paras. 0043, 0066, and 0076-0077; an electromagnetic tracking (EM) system having the EM localizer 94. Either or both of the tracking systems can be used to tracked selected tracking devices. As each of the tracking devices 160, and others as discussed herein, may be connected to the subject, they may also be used to maintain and/or confirm registration. The tracking devices 160 may include a single tracking modality (e.g. optical or EM) while the patient tracker 58 may include multiple tracking modalities (e.g. both optical and EM) to allow for correlation between the two tracking modalities. The examiner notes that the electromagnetic tracking system is able to receive signals from a sensor to determine the pose using the EM locator and the EM sensor is disposed on the tracking devices 160 attached to the vertebrae);
an ultrasound (US) navigation system configured to determine a pose of an US tracking device in response to receiving an US signal (paras. 0043 and 0076; It is further understood that additional or alternative tracking systems may also be used, such as radar, acoustic, ultrasonic, and/or other tracking systems. Generally, the tracking system tracks the tracking device in the tracking or navigation space. The tracking system is able to generate a signed based on the tracking (e.g. within a field of view of a camera, EM field, etc.) and the signal is used within the navigation system to determine the position of the tracked element. The examiner notes that instead of the optical tracking system an ultrasound tracking system can be used to track the position of tracking devices attached to the patient vertebrae);
a transducer configured to emit an EM signal in response to detecting the EM field, wherein the transducer is configured to be associated with a portion of a subject that is a segmented portion in an image (paras. 0066, 0069, and 0077; In addition to the subject tracker 58, additional tracking elements may also be affixed to the patient 30 including individual or separate member trackers 160, including a selected number for example, 3, including 160i, 160ii, and 160iii. Each of the individual trackers 160 may also be referred to as tracking devices and may be fixed to different bony portions that may be movable relative to one another, such as different vertebrae including a first vertebra 166i, second vertebra 166ii, and a third vertebra 166iii. As discussed above, the tracking system may track the bony portions or the tracking devices connected to the bony portions in real time. The image 108 may include image data or images of the vertebrae, such as the first vertebra 166i′ and the second vertebra 166ii′. The vertebrae, include each vertebra, may be segmented in the image in any appropriate manner, such as in a substantially automatic process, manual process, or a combination of manual and automatic processes. It is understood, however, that other tracking devices, such as the subject member tracking device 160 may include only a single tracking modality or type of tracker, such as an EM tracker. According to various embodiments, therefore, the individual member trackers 160 may only include a single type of tracking device. In various embodiments, the EM tracking devices may include one or more members of conductive material formed into coils that may sense and/or emit and electromagnetic field.);
a display device configured to display the image (para. 0072; display device 84 displaying an image);
a processor module configured to execute instructions to (para. 0050; The image data can then be forwarded from the image device controller 96 to the navigation computer and/or processor system 102 that can be a part of a controller or work station 98 having a display 84 and a user interface 106):
segment the image to define the segmented portion (para. 0069; An automatic segmentation may include a processor, such as the processor 102, executing an algorithm to segment the vertebrae in the image.),
determine a pose of the segmented portion based on the tracking of the transducer (para. 0089; the individual tracking devices, including the individual tracking devices 160 connected to the member, such as the vertebra 166, the instrument tracking device 66, and other tracking devices are tracked in block 298. Tracking the tracking devices in block 298 may include determining positions of the tracking devices in the navigation space. Tracking the tracking devices in block 298 allows for determination of positions of portions that are connected to the tracking devices, such as the individual member portions including the vertebrae 166.),
update the displayed image to include a real time pose of the segmented portion based on the determined pose (para. 0089; Accordingly, in block 304 the image 108 may be updated, including the segmented image portions thereof, may be updated based upon the tracked positions of the individual tracking devices. As illustrated in FIG. 4 and FIG. 5, the image portions of the vertebrae 166i′ and 166ii′ may be displayed based upon a tracked position of the tracking devices associated thereto. Thus, the tracking devices 160 track the related portions, such as the vertebrae 166, which may be moved and the image portions 166′ related thereto may be changed or updated on the image 108 displayed on the display device 64.).
Although Snyder teach that the tracking device 160 can include ultrasound tracking modality or electromagnetic tracking modality, however, Snyder fails to explicitly teach that the tracking devices 160 are an electromagnetic-ultrasound transducer (EMUST) configured to emit both an EM signal and an US signal in response to detecting the EM field.
Govari, in the same field of endeavor, teaches an electromagnetic-ultrasound transducer (EMUST) configured to emit both an EM signal and an US signal in response to detecting the EM field (col 2, 49-58; An RF-responsive transducer, having a resonant vibrational frequency in the ultrasonic range, is fixed to an object and is irradiated with an RF energy field. The transducer is induced to vibrate and emits energy, either RF or ultrasonic energy, or both, responsive to an interaction of the RF field with the vibration. The emitted energy is detected and is used to determine position and/or orientation coordinates of the object.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured emit both an EM signal and an US signal in response to detecting the EM field. Doing so would enable the system to determine both the position and orientation coordinate of the object more accurately. Using both modalities to track the pose of a portion of a subject would combine the strength of both modalities and if one modality is disrupted the other can compensate and doing so would be ideal for precise, real-time pose tracking in surgical navigation.
Regarding claim 2, Snyder teaches the system of Claim 1, wherein the processor determines the pose of the segmented portion based only on the transducer signals (paras 0068-0069; Similarly, or in addition thereto, the member trackers 160, such as the tracker 160i may also communicate with the navigation system 20 via a wired communication, wireless communication, or combination thereof. As illustrated in FIG. 2 and FIG. 3, the vertebrae, including the first vertebra 166i and the second vertebra 166ii may each include or have connected thereto a respective tracker or tracking device 160i, 160ii, respectively. Accordingly, each of the tracking devices 160 may track a selected member or element, such as the bony portion including the vertebrae 166.).
However, fails to explicitly teach determined pose of the portion based only on the EMUST US signal (col 6, lines 44-50; The ultrasonic signals generated by transducer 12 are transduced by detectors 34, 36, and 38, into electrical signals which are passed to signal processor 30, in either analog or digital form. Signal processor 30 processes the outputs of the detectors to calculate the position and/or orientation of the locating transducer 12, and transmits this information to a display monitor 28 and/or control unit 32).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to an electromagnetic-ultrasound transducer (EMUST) configured to transduce both an EM signal and an US signal and determining the pose of the segmented portion is based only on the EMUST US signal. Doing so would enable the system to determine both the position and orientation coordinate of the device more accurately. Relying on the US signal to determine the pose would enable accurate distance measurement by using triangulation techniques that refine the calculate pose.
Regarding claim 5, Snyder teaches the system of Claim 1, further comprising: a tracking assembly having the EM tracking device and the US tracking device, wherein the EM tracking device is configured to at least one of emit or sense an EM field and the US tracking device is configured to at least one of emit or sense an US signal (para. 0051; the navigation system 20 can further include the tracking system which may be one or both of the electromagnetic (EM) localizer 94 and/or the optical localizer 88. As noted above, however, more or alternative tracking systems may also be provided or used. Other tracking systems include an acoustic, radiation, radar, etc. ).
Regarding claim 6, Snyder teaches the system Claim 5, further comprising: an instrument operable to be moved relative to the portion of the subject (para. 0042; When navigating the instrument 68, a position of the instrument 68 can be illustrated relative to image data acquired of the patient 30 on a display device 84. Various tracking systems, such as one including the optical localizer 88 or the electromagnetic (EM) localizer 92 can be used to track the instrument 68.);
wherein the tracking assembly is associated with the instrument (paras. 0042-0043 and 0053; When navigating the instrument 68, a position of the instrument 68 can be illustrated relative to image data acquired of the patient 30 on a display device 84. Various tracking systems, such as one including the optical localizer 88 or the electromagnetic (EM) localizer 92 can be used to track the instrument 68. It is further understood that additional or alternative tracking systems may also be used, such as radar, acoustic, ultrasonic, and/or other tracking systems. Various portions of the navigation system 20, such as the instrument 68, and others as will be described in detail below, can be equipped with at least one, and generally multiple, of the tracking devices 66. The instrument can also include more than one type or modality of tracking device 66, such as an EM tracking device 66e and/or an optical tracking device 66o.);
wherein a pose of the transducer is operable to be determined at least in a US navigation space to determine the real time pose of the portion (paras. 0037, 0043, and 0086, the examiner notes that the system registers both tracking coordinate system together and the pose of the portion is tracked in both coordinate systems due to the registration of both systems).
Although Snyder teach that the tracking device 160 can include ultrasound tracking modality or electromagnetic tracking modality, however, Snyder fails to explicitly teach that the tracking devices 160 are an electromagnetic-ultrasound transducer (EMUST) configured to emit both an EM signal and an US signal.
Govari, in the same field of endeavor, teaches an electromagnetic-ultrasound transducer (EMUST) configured to emit both an EM signal and an US signal (col 2, 49-58; An RF-responsive transducer, having a resonant vibrational frequency in the ultrasonic range, is fixed to an object and is irradiated with an RF energy field. The transducer is induced to vibrate and emits energy, either RF or ultrasonic energy, or both, responsive to an interaction of the RF field with the vibration. The emitted energy is detected and is used to determine position and/or orientation coordinates of the object.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured emit both an EM signal and an US signal. Doing so would enable the system to determine both the position and orientation coordinate of the object more accurately. Using both modalities to track the pose of a portion of a subject would combine the strength of both modalities and if one modality is disrupted the other can compensate and doing so would be ideal for precise, real-time pose tracking in surgical navigation.
Regarding claim 7, Snyder teaches the system of Claim 6, wherein the instrument generates distortions that affect the EM field sensed at least by the EM tracking device (para. 0116; the instrument causes distortion in the EM field sensed by the tracking device).
Regarding claim 8, Snyder teaches the system of Claim 1, wherein the EM navigation system includes an EM localizer that emits the EM field (para. 0043; an electromagnetic tracking (EM) system having the EM localizer 94).
However, fails to explicitly teach wherein the EM field is operable to cause the EMUST to emit the US signal.
Govari, in the same field of endeavor, teaches EM field is operable to cause the EMUST to emit the US signal (Col 2, lines 49-58 and col 6, lines 12-23; the RF radiation is initiated by control signals from a control unit 32 which cause an RF radiator driver 26 to generate driving signals. The driving signals in turn cause one or more RF radiators 40, 42 and 44 located outside a body surface 24 of the patient to emit RF radiation. A representation of the driving signals is also sent to a signal processor 30. The ultrasonic radiation from locating transducer 12, generated by one or more resonating crystal/foil units, is detected by a plurality of ultrasound detectors 34, 36, and 38.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to an electromagnetic-ultrasound transducer (EMUST) configured to transduce both an EM signal and an US signal, wherein EM field is operable to cause the EMUST to emit the US signal. Doing so would enable the system to determine both the position and orientation coordinate of the device inside the body more accurately. Using both modalities to track the pose of a portion of a subject would combine the strength of both modalities and if one modality is disrupted the other can compensate and doing so would be ideal for precise, real-time pose tracking in surgical navigation. The emitted US signal based on EM field simulation is beneficial because the emitted ultrasonic waves as a function of RF excitation frequency can be used by processor to determine both the position and the orientation of transducer.
Regarding claim 9, Snyder teaches the system of Claim 1, wherein the US navigation system includes a single US receiver configured to receive a signal (para. 0043; More than one tracking system can be used to track the instrument 68 in the navigation system 20. According to various embodiments, these can include an electromagnetic tracking (EM) system having the EM localizer 94 and/or an optical tracking system having the optical localizer 88. Either or both of the tracking systems can be used to tracked selected tracking devices, as discussed herein. It will be understood, unless discussed otherwise, that a tracking device can be a portion trackable with a selected tracking system. A tracking device need not refer to the entire member or structure to which the tracking device is affixed or associated. It is further understood that additional or alternative tracking systems may also be used, such as radar, acoustic, ultrasonic, and/or other tracking systems. Generally, the tracking system tracks the tracking device in the tracking or navigation space. The tracking system is able to generate a signed based on the tracking (e.g. within a field of view of a camera, EM field, etc.) and the signal is used within the navigation system to determine the position of the tracked element. In various embodiments, the determined position may then be illustrated on a display device relative to another coordinate system, such as image space. The examiner notes that the tracking system comprise a localizer that emits and receives signals from and to trackable transducer. The tracking system can be an ultrasound tracking system that receives ultrasound signals).
Although Snyder teaches that the tracking system can include an ultrasound localizer, however, fails to explicitly teach US receiver configured to receive a signal operable to allow a determination of at least a distance between the single US receiver and the EMUST.
Govari, in the same field of endeavor, teaches US receiver configured to receive a signal operable to allow a determination of at least a distance between the single US receiver and the EMUST (col 7, lines 7-20; The signal processor preferably uses the initiation time of the driving signal to RF radiator 40, the time of arrival at each detector of the acoustic radiation from unit 112, and the speed of sound in tissue, in order to determine the distances from the unit 112 to each of the detectors. The initiation time of a driving signal is substantially the same time as that when acoustic radiation leaves a crystal/foil unit, so the signal processor calculates the "time of flight" of acoustic radiation from unit 112 to each of the detectors, and multiplies each of these times by the speed of sound in tissue to yield the distances from unit 112 to each detector. With these distances, signal processor 30 calculates three-dimensional position coordinates of transducer 12 with respect to a reference frame, using methods known in the art.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured to transduce both an EM signal and an US signal and an US receiver configured to receive a signal operable to allow a determination of at least a distance between the single US receiver and the EMUST. Doing so would enable the system to determine both the position and orientation coordinate of the device more accurately. Relying on the US signal to determine the pose would enable accurate distance measurement by using triangulation techniques that refine the calculate pose.
Regarding claim 10, Snyder teaches the system of Claim 1, however, fails to explicitly teach wherein the US navigation system includes a plurality of US receivers; wherein each US receiver of the plurality of US receivers is configured to receive a signal operable to allow a determination of a distance between the EMUST and each of the US receivers.
Govari, in the same field of endeavor, teaches wherein the US navigation system includes a plurality of US receivers; wherein each US receiver of the plurality of US receivers is configured to receive a signal operable to allow a determination of a distance between the EMUST and each of the US receivers (col 7, lines 7-20; The signal processor preferably uses the initiation time of the driving signal to RF radiator 40, the time of arrival at each detector of the acoustic radiation from unit 112, and the speed of sound in tissue, in order to determine the distances from the unit 112 to each of the detectors. The initiation time of a driving signal is substantially the same time as that when acoustic radiation leaves a crystal/foil unit, so the signal processor calculates the "time of flight" of acoustic radiation from unit 112 to each of the detectors, and multiplies each of these times by the speed of sound in tissue to yield the distances from unit 112 to each detector. With these distances, signal processor 30 calculates three-dimensional position coordinates of transducer 12 with respect to a reference frame, using methods known in the art.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured to transduce both an EM signal and an US signal and a plurality of US receivers configured to receive a signal operable to allow a determination of at least a distance between the plurality US receiver and the EMUST. Doing so would enable the system to determine both the position and orientation coordinate of the device inside the body more accurately. Relying on the US signal to determine the pose would enable accurate distance measurement by using triangulation techniques that refine the calculate pose. Additionally, using multiple US receivers allow the three components of the angular orientation vector of the object, as well as the three position vector components to be calculated based on the signals from the ultrasound detectors, which will result in accurate localization of the transducer.
Regarding claim 11, Snyder teaches the system of Claim 1, wherein the transucer includes a plurality of transducers (para. 0066; additional tracking elements may also be affixed to the patient 30 including individual or separate member trackers 160, including a selected number for example, 3, including 160i, 160ii, and 160iii. Each of the individual trackers 160 may also be referred to as tracking devices and may be fixed to different bony portions that may be movable relative to one another, such as different vertebrae including a first vertebra 166i, second vertebra 166ii, and a third vertebra 166iii. Accordingly, each vertebra of the vertebrae 166 may move relative to one another, such as the first vertebra 166i and the second vertebra 166ii. The individual trackers 160 connected to the individual vertebra may allow for tracking of the individual vertebra relative to one another, as discussed further herein.); wherein the portion includes a plurality of portions; wherein each transducer of the plurality of transducers is associated with each portion of the plurality of portions (para. 0066; additional tracking elements may also be affixed to the patient 30 including individual or separate member trackers 160, including a selected number for example, 3, including 160i, 160ii, and 160iii. Each of the individual trackers 160 may also be referred to as tracking devices and may be fixed to different bony portions that may be movable relative to one another, such as different vertebrae including a first vertebra 166i, second vertebra 166ii, and a third vertebra 166iii. Accordingly, each vertebra of the vertebrae 166 may move relative to one another, such as the first vertebra 166i and the second vertebra 166ii. The individual trackers 160 connected to the individual vertebra may allow for tracking of the individual vertebra relative to one another, as discussed further herein.).
Although Snyder teach that the tracking device 160 can include ultrasound tracking modality or electromagnetic tracking modality, however, Snyder fails to explicitly teach that the tracking devices 160 are an electromagnetic-ultrasound transducer (EMUST) configured to emit both an EM signal and an US signal.
Govari, in the same field of endeavor, teaches an electromagnetic-ultrasound transducer (EMUST) configured to transduce both an EM signal and an US signal (col 2, 49-58; An RF-responsive transducer, having a resonant vibrational frequency in the ultrasonic range, is fixed to an object and is irradiated with an RF energy field. The transducer is induced to vibrate and emits energy, either RF or ultrasonic energy, or both, responsive to an interaction of the RF field with the vibration. The emitted energy is detected and is used to determine position and/or orientation coordinates of the object.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured emit both an EM signal and an US signal. Doing so would enable the system to determine both the position and orientation coordinate of the object more accurately. Using both modalities to track the pose of a portion of a subject would combine the strength of both modalities and if one modality is disrupted the other can compensate and doing so would be ideal for precise, real-time pose tracking in surgical navigation.
Regarding claim 12, Snyder teaches the system of Claim 11, however, fails to explicitly teach wherein the US navigation system includes at least one of a plurality of US receivers, wherein each US receiver of the plurality of US receivers is configured to receive a signal operable to allow a determination of a distance between the EMUST and each of the US receivers.
Govari, in the same field of endeavor, teaches the US navigation system includes at least one of a plurality of US receivers, wherein each US receiver of the plurality of US receivers is configured to receive a signal operable to allow a determination of a distance between the EMUST and each of the US receivers (col 7, lines 7-20; The signal processor preferably uses the initiation time of the driving signal to RF radiator 40, the time of arrival at each detector of the acoustic radiation from unit 112, and the speed of sound in tissue, in order to determine the distances from the unit 112 to each of the detectors. The initiation time of a driving signal is substantially the same time as that when acoustic radiation leaves a crystal/foil unit, so the signal processor calculates the "time of flight" of acoustic radiation from unit 112 to each of the detectors, and multiplies each of these times by the speed of sound in tissue to yield the distances from unit 112 to each detector. With these distances, signal processor 30 calculates three-dimensional position coordinates of transducer 12 with respect to a reference frame, using methods known in the art.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured to transduce both an EM signal and an US signal and a plurality of US receivers configured to receive a signal operable to allow a determination of at least a distance between the plurality US receiver and the EMUST. Doing so would enable the system to determine both the position and orientation coordinate of the device inside the body more accurately. Relying on the US signal to determine the pose would enable accurate distance measurement by using triangulation techniques that refine the calculate pose. Additionally, using multiple US receivers allow the three components of the angular orientation vector of the object, as well as the three position vector components to be calculated based on the signals from the ultrasound detectors, which will result in accurate localization of the transducer.
Regarding claim 13, Snyder teaches a method for navigating a procedure, comprising (para. 0037; the navigation system):
Emitting an electromagnetic (EM) simulation field with an EM navigation system to and determining a pose of an EM tracking device based on received EM signals (paras. 0043, 0066, and 0076-0077; an electromagnetic tracking (EM) system having the EM localizer 94. Either or both of the tracking systems can be used to tracked selected tracking devices. As each of the tracking devices 160, and others as discussed herein, may be connected to the subject, they may also be used to maintain and/or confirm registration. The tracking devices 160 may include a single tracking modality (e.g. optical or EM) while the patient tracker 58 may include multiple tracking modalities (e.g. both optical and EM) to allow for correlation between the two tracking modalities. The examiner notes that the electromagnetic tracking system is able to receive signals from a sensor to determine the pose using the EM locator and the EM sensor is disposed on the tracking devices 160 attached to the vertebrae);
Receiving an ultrasound (US) signal with an US navigation system and determining a pose of an US tracking device based on received US signals (paras. 0043 and 0076; It is further understood that additional or alternative tracking systems may also be used, such as radar, acoustic, ultrasonic, and/or other tracking systems. Generally, the tracking system tracks the tracking device in the tracking or navigation space. The tracking system is able to generate a signed based on the tracking (e.g. within a field of view of a camera, EM field, etc.) and the signal is used within the navigation system to determine the position of the tracked element. The examiner notes that instead of the optical tracking system an ultrasound tracking system can be used to track the position of tracking devices attached to the patient vertebrae);
providing a plurality of transducers including a first transducer and a second transducer that are each configured to emit a respective EM signal, wherein each of the transducers is configured to be associated with a respective portion of a subject that is a respective segmented portion of a plurality of segmented portions in an image (paras. 0066, 0069, and 0077; In addition to the subject tracker 58, additional tracking elements may also be affixed to the patient 30 including individual or separate member trackers 160, including a selected number for example, 3, including 160i, 160ii, and 160iii. Each of the individual trackers 160 may also be referred to as tracking devices and may be fixed to different bony portions that may be movable relative to one another, such as different vertebrae including a first vertebra 166i, second vertebra 166ii, and a third vertebra 166iii. As discussed above, the tracking system may track the bony portions or the tracking devices connected to the bony portions in real time. The image 108 may include image data or images of the vertebrae, such as the first vertebra 166i′ and the second vertebra 166ii′. The vertebrae, include each vertebra, may be segmented in the image in any appropriate manner, such as in a substantially automatic process, manual process, or a combination of manual and automatic processes. It is understood, however, that other tracking devices, such as the subject member tracking device 160 may include only a single tracking modality or type of tracker, such as an EM tracker. According to various embodiments, therefore, the individual member trackers 160 may only include a single type of tracking device. In various embodiments, the EM tracking devices may include one or more members of conductive material formed into coils that may sense and/or emit and electromagnetic field.);
operating a display device configured to display the image (para. 0072; display device 84 displaying an image);
operating a processor module configured to execute instructions to (para. 0050; The image data can then be forwarded from the image device controller 96 to the navigation computer and/or processor system 102 that can be a part of a controller or work station 98 having a display 84 and a user interface 106):
segment the image to define the segmented portion (para. 0069; An automatic segmentation may include a processor, such as the processor 102, executing an algorithm to segment the vertebrae in the image.),
determine a pose of each portion based on a tracking of the respective transducer (para. 0089; the individual tracking devices, including the individual tracking devices 160 connected to the member, such as the vertebra 166, the instrument tracking device 66, and other tracking devices are tracked in block 298. Tracking the tracking devices in block 298 may include determining positions of the tracking devices in the navigation space. Tracking the tracking devices in block 298 allows for determination of positions of portions that are connected to the tracking devices, such as the individual member portions including the vertebrae 166.),
update the displayed image to include a real time pose of the segmented portions based on the determined pose of each portion(para. 0089; Accordingly, in block 304 the image 108 may be updated, including the segmented image portions thereof, may be updated based upon the tracked positions of the individual tracking devices. As illustrated in FIG. 4 and FIG. 5, the image portions of the vertebrae 166i′ and 166ii′ may be displayed based upon a tracked position of the tracking devices associated thereto. Thus, the tracking devices 160 track the related portions, such as the vertebrae 166, which may be moved and the image portions 166′ related thereto may be changed or updated on the image 108 displayed on the display device 64.).
Although Snyder teach that the tracking device 160 can include ultrasound tracking modality or electromagnetic tracking modality, however, Snyder fails to explicitly teach that the tracking devices 160 are an electromagnetic-ultrasound transducer (EMUST) configured to emit an EM signal and an US signal, wherein the first EMUST is configured to emit a first US signal at a first frequency and the second EMUST is configured to emit a second US signal at a second frequency different from the first frequency.
Govari, in the same field of endeavor, teaches an electromagnetic-ultrasound transducer (EMUST) configured to emit an EM signal and an US signal (col 2, 49-58; An RF-responsive transducer, having a resonant vibrational frequency in the ultrasonic range, is fixed to an object and is irradiated with an RF energy field. The transducer is induced to vibrate and emits energy, either RF or ultrasonic energy, or both, responsive to an interaction of the RF field with the vibration. The emitted energy is detected and is used to determine position and/or orientation coordinates of the object.), wherein the first EMUST is configured to emit a first US signal at a first frequency and the second EMUST is configured to emit a second US signal at a second frequency different from the first frequency (col 7, lines 21-43; major axes 63 and 65 of two crystal/foil units 114 and 116 are continuous with the longitudinal axis of the catheter. Unit 114 comprises a piezoelectric crystal 62 which has a resonant frequency, a first foil member 94 coupled to a first side of crystal 62, and a second foil member (not shown) coupled to a second side of crystal 62. Unit 116 comprises a piezoelectric crystal 64 which has a resonant frequency substantially different from that of crystal 62, a first foil member 96 coupled to a first side of crystal 64, and a second foil member (not shown) coupled to a second side of piezoelectric crystal 64.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured emit both an EM signal and an US signal, wherein the first EMUST is configured to emit a first US signal at a first frequency and the second EMUST is configured to emit a second US signal at a second frequency different from the first frequency. Doing so would enable the system to determine both the position and orientation coordinate of the object more accurately. Using both modalities to track the pose of a portion of a subject would combine the strength of both modalities and if one modality is disrupted the other can compensate and doing so would be ideal for precise, real-time pose tracking in surgical navigation. Additionally, using different emission frequencies allows the ultrasound emissions from each transducer to be distinguished by signal processor, and the spatial location of each unit is determined with respect to a reference frame as disclosed within Govari in col 7, lines 21-43.
Regarding claim 14, Snyder teaches the method of Claim 13, however, fails to explicitly teach wherein operating the processor module to execute instructions to determine pose of each portion based on the tracking of the respective transducer (paras 0068-0069; Similarly, or in addition thereto, the member trackers 160, such as the tracker 160i may also communicate with the navigation system 20 via a wired communication, wireless communication, or combination thereof. As illustrated in FIG. 2 and FIG. 3, the vertebrae, including the first vertebra 166i and the second vertebra 166ii may each include or have connected thereto a respective tracker or tracking device 160i, 160ii, respectively. Accordingly, each of the tracking devices 160 may track a selected member or element, such as the bony portion including the vertebrae 166.).
However, fails to explicitly teach determined pose of the portion based tracking of the respective transducer is based only on the respective EMUST US signal(col 7, lines 21-43; major axes 63 and 65 of two crystal/foil units 114 and 116 are continuous with the longitudinal axis of the catheter. Unit 114 comprises a piezoelectric crystal 62 which has a resonant frequency, a first foil member 94 coupled to a first side of crystal 62, and a second foil member (not shown) coupled to a second side of crystal 62. Unit 116 comprises a piezoelectric crystal 64 which has a resonant frequency substantially different from that of crystal 62, a first foil member 96 coupled to a first side of crystal 64, and a second foil member (not shown) coupled to a second side of piezoelectric crystal 64. Using methods described hereinbelow, the ultrasound emissions from crystal/foil units 114 and 116 are distinguished by signal processor 30, and the spatial location of each unit is determined with respect to a reference frame. Calculation of the three-dimensional position coordinates of each of units 114 and 116 determines both the location of the catheter and the orientation of its longitudinal axis.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured to transduce both an EM signal and an US signal and determining the pose of the portion is based only on the EMUST US signal. Doing so would enable the system to determine both the position and orientation coordinate of the device more accurately. Relying on the US signal to determine the pose would enable accurate distance measurement by using triangulation techniques that refine the calculate pose.
Regarding claim 15, Snyder teaches the method of Claim 13, however, fails to explicitly teach wherein each EMUST is configured to emit both the respective EM signal and the respective US signal in response to detecting the EM field.
Govari, in the same field of endeavor, teaches an electromagnetic-ultrasound transducer (EMUST) configured to emit both an EM signal and an US signal in response to detecting the EM field (col 2, 49-58; An RF-responsive transducer, having a resonant vibrational frequency in the ultrasonic range, is fixed to an object and is irradiated with an RF energy field. The transducer is induced to vibrate and emits energy, either RF or ultrasonic energy, or both, responsive to an interaction of the RF field with the vibration. The emitted energy is detected and is used to determine position and/or orientation coordinates of the object.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured emit both an EM signal and an US signal in response to detecting the EM field. Doing so would enable the system to determine both the position and orientation coordinate of the object more accurately. Using both modalities to track the pose of a portion of a subject would combine the strength of both modalities and if one modality is disrupted the other can compensate and doing so would be ideal for precise, real-time pose tracking in surgical navigation.
Regarding claim 16, Snyder teaches the method of Claim 13, providing a single US receiver in the US navigation system to receive the first US signal (para. 0043; More than one tracking system can be used to track the instrument 68 in the navigation system 20. According to various embodiments, these can include an electromagnetic tracking (EM) system having the EM localizer 94 and/or an optical tracking system having the optical localizer 88. Either or both of the tracking systems can be used to tracked selected tracking devices, as discussed herein. It will be understood, unless discussed otherwise, that a tracking device can be a portion trackable with a selected tracking system. A tracking device need not refer to the entire member or structure to which the tracking device is affixed or associated. It is further understood that additional or alternative tracking systems may also be used, such as radar, acoustic, ultrasonic, and/or other tracking systems. Generally, the tracking system tracks the tracking device in the tracking or navigation space. The tracking system is able to generate a signed based on the tracking (e.g. within a field of view of a camera, EM field, etc.) and the signal is used within the navigation system to determine the position of the tracked element. In various embodiments, the determined position may then be illustrated on a display device relative to another coordinate system, such as image space. The examiner notes that the tracking system comprise a localizer that emits and receives signals from and to trackable transducer. The tracking system can be an ultrasound tracking system that receives ultrasound signals).
Although Snyder teaches that the tracking system can include an ultrasound localizer, however, fails to explicitly teach US receiver configured to receive the first US signal and operable to allow a determination of at least a distance between the single US receiver and the first EMUST.
Govari, in the same field of endeavor, teaches US receiver configured to receive the first US signal and operable to allow a determination of at least a distance between the single US receiver and the first EMUST (col 7, lines 7-20; The signal processor preferably uses the initiation time of the driving signal to RF radiator 40, the time of arrival at each detector of the acoustic radiation from unit 112, and the speed of sound in tissue, in order to determine the distances from the unit 112 to each of the detectors. The initiation time of a driving signal is substantially the same time as that when acoustic radiation leaves a crystal/foil unit, so the signal processor calculates the "time of flight" of acoustic radiation from unit 112 to each of the detectors, and multiplies each of these times by the speed of sound in tissue to yield the distances from unit 112 to each detector. With these distances, signal processor 30 calculates three-dimensional position coordinates of transducer 12 with respect to a reference frame, using methods known in the art.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured to transduce both an EM signal and an US signal and an US receiver configured to receive a signal operable to allow a determination of at least a distance between the single US receiver and the EMUST. Doing so would enable the system to determine both the position and orientation coordinate of the device more accurately. Relying on the US signal to determine the pose would enable accurate distance measurement by using triangulation techniques that refine the calculate pose.
Regarding claim 17, Snyder teaches the method of Claim 13, however, fails to explicitly teach providing a plurality of US receivers in the US navigation system; operating each US receiver of the plurality of US receivers to receive the US signal operable to allow a determination of a distance between the EMUST and each of the US receivers.
Govari, in the same field of endeavor, teaches wherein the US navigation system includes a plurality of US receivers; wherein each US receiver of the plurality of US receivers is configured to receive a signal operable to allow a determination of a distance between the EMUST and each of the US receivers (col 7, lines 7-20; The signal processor preferably uses the initiation time of the driving signal to RF radiator 40, the time of arrival at each detector of the acoustic radiation from unit 112, and the speed of sound in tissue, in order to determine the distances from the unit 112 to each of the detectors. The initiation time of a driving signal is substantially the same time as that when acoustic radiation leaves a crystal/foil unit, so the signal processor calculates the "time of flight" of acoustic radiation from unit 112 to each of the detectors, and multiplies each of these times by the speed of sound in tissue to yield the distances from unit 112 to each detector. With these distances, signal processor 30 calculates three-dimensional position coordinates of transducer 12 with respect to a reference frame, using methods known in the art.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured to transduce both an EM signal and an US signal and a plurality of US receivers configured to receive a signal operable to allow a determination of at least a distance between the plurality US receiver and the EMUST. Doing so would enable the system to determine both the position and orientation coordinate of the device inside the body more accurately. Relying on the US signal to determine the pose would enable accurate distance measurement by using triangulation techniques that refine the calculate pose. Additionally, using multiple US receivers allow the three components of the angular orientation vector of the object, as well as the three position vector components to be calculated based on the signals from the ultrasound detectors, which will result in accurate localization of the transducer.
Regarding claim 19, Snyder teaches the method of Claim 18, however, fails to explicitly teach providing a plurality of US receivers, wherein each US receiver of the plurality of US receivers is configured to receive a signal operable to allow a determination of a distance between each EMUST and each of the US receivers.
Govari, in the same field of endeavor, teaches wherein the US navigation system includes a plurality of US receivers; wherein each US receiver of the plurality of US receivers is configured to receive a signal operable to allow a determination of a distance between the EMUST and each of the US receivers (col 7, lines 7-20; The signal processor preferably uses the initiation time of the driving signal to RF radiator 40, the time of arrival at each detector of the acoustic radiation from unit 112, and the speed of sound in tissue, in order to determine the distances from the unit 112 to each of the detectors. The initiation time of a driving signal is substantially the same time as that when acoustic radiation leaves a crystal/foil unit, so the signal processor calculates the "time of flight" of acoustic radiation from unit 112 to each of the detectors, and multiplies each of these times by the speed of sound in tissue to yield the distances from unit 112 to each detector. With these distances, signal processor 30 calculates three-dimensional position coordinates of transducer 12 with respect to a reference frame, using methods known in the art.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured to transduce both an EM signal and an US signal and a plurality of US receivers configured to receive a signal operable to allow a determination of at least a distance between the plurality US receiver and the EMUST. Doing so would enable the system to determine both the position and orientation coordinate of the device inside the body more accurately. Relying on the US signal to determine the pose would enable accurate distance measurement by using triangulation techniques that refine the calculate pose. Additionally, using multiple US receivers allow the three components of the angular orientation vector of the object, as well as the three position vector components to be calculated based on the signals from the ultrasound detectors, which will result in accurate localization of the transducer.
Regarding claim 21, Snyder teaches the system of Claim 2, wherein the processor module is further configured to execute instructions to determine the pose of the portion based on the tracking of the transducer based only on the US signal when the EM navigation system detects a selected amount of interference (paras. 0116 and 0125-0126; the instrument 68 includes the tracking device 66 that may include one or more tracking portions, such as an optical tracking portion 66o and an EM tracking portion 66e. Accordingly, the instrument 68 may be tracked with both of the localizers 88, 94 substantially simultaneously. The two localizers having the two respective coordinate systems may be correlated, as discussed above. Tracking the instrument 68 in the two coordinate systems may be used to assist in increasing confidence of a tracked position of the instrument 68. The tracked position of the instrument 68 may be tracked with the two tracking systems and the tracked location may be confirmed and/or increased in confidence by tracking with the two tracking systems and/or selecting the tracking system with the least amount of error. Further, the instrument 68 may be tracked substantially continuously, therefore, regardless of interference with either one of the tracking systems. In addition, moving the instrument 68 through space and maintaining tracking it with the two tracking systems may allow for determination of possible interference in different areas of space to either or both of the tracking systems. Noise or spurious spectral components could also be used to weight a measurement by signal quality or the presence of interference. The examiner notes that the system uses both optical and electromagnetic for position tracking, however, ultrasound can be used as an alternative to optical trackers. The system detects an amount of error in the signal such as (interference or distortion) and decides to use the other tracking modality to track the position. For example, the system determines an amount of error in the electromagnetic signal due to interference/distortion and uses the other tracking modality (ultrasound signal) to determine the position of the tracked object).
Although Snyder teach that the tracking device can include ultrasound tracking modality or electromagnetic tracking modality, however, Snyder fails to explicitly teach that the tracking devices are an electromagnetic-ultrasound transducer (EMUST) configured to transduce both an EM signal and an US signal.
Govari, in the same field of endeavor, teaches an electromagnetic-ultrasound transducer (EMUST) configured to emit both an EM signal and an US signal in response to detecting the EM field (col 2, 49-58; An RF-responsive transducer, having a resonant vibrational frequency in the ultrasonic range, is fixed to an object and is irradiated with an RF energy field. The transducer is induced to vibrate and emits energy, either RF or ultrasonic energy, or both, responsive to an interaction of the RF field with the vibration. The emitted energy is detected and is used to determine position and/or orientation coordinates of the object.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the tracking modality of the tracking devices of Snyder with the RF responsive transducer of Govari to provide an electromagnetic-ultrasound transducer (EMUST) configured emit both an EM signal and an US signal in response to detecting the EM field. Doing so would enable the system to determine both the position and orientation coordinate of the object more accurately. Using both modalities to track the pose of a portion of a subject would combine the strength of both modalities and if one modality is disrupted the other can compensate and doing so would be ideal for precise, real-time pose tracking in surgical navigation.
Regarding claim 22, Snyder teaches the system of Claim 5, wherein the EM navigation system is co-registered with the US navigation system based at least on the tracking assembly (paras. 0037 and 0043; the navigation system 20 may include various elements or portions, such as an optical localizer 88 and an electromagnetic (EM) localizer 94, which define or are used to generate navigation or tracking spaces in selected first and/or second coordinate systems, as discussed further herein. The respective localizers 88, 94 may also be registered, also referred to as correlated, relative to one another, as also discussed further herein, to allow for tracking one or more instruments in either or both of the coordinate systems and relating the tracked position to an additional coordinate system. Accordingly, the user 72 may track one or more instruments, such as an instrument 68 relative to a subject 30 and/or track plurality of portions or members of the subject 30. The examiner notes that Snyder disclose that the optical tracking system can be substituted with ultrasound tracking system, therefore, registering both tracking systems relative to each other).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carey Michael can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZAINAB MOHAMMED ALDARRAJI/Patent Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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