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 .
Status of Claims
Claims 1-21 are pending in this application. Claims 1-21 have been examined on the merits.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 11-13, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US20190046155A1) in view of Palushi (US20200188031A1).
Regarding Claim 1,
Govari teaches a method, comprising: capturing position data for a first plurality of registration points along a face of a head of a patient (corresponding disclosure in at least [0020], where position data is captured of a face of a head of a patient “An operator can then see the target on the image S and register areas of the patient's face on the image S for later use in an ENT procedure”),
the position data for the first plurality of registration points being captured based on signals from a position sensor of a registration probe as the registration probe is positioned at each registration point of the first plurality of registration points (corresponding disclosure in at least [0032], where position data is received via signals from a registration probe “an operator hovers or touches the registration probe over a reference point on the patient's face to register that target location on the image”),
each of the signals from the position sensor indicating a corresponding real-time position of the position sensor in three-dimensional space (corresponding disclosure in at least [0034], where the position sensor indicates the probe sensor in real-time “ A physician monitoring the convergence of the probe 110 in real time on the image, (e.g., CT scan), may determine that a sufficient amount of the patient's face has been registered” and further in [0024], where the position is determined in three-dimensional space “the location that the coils 113 determine the registration probe 110 exists in three-dimensional space based on the magnetic field or fields received from the magnetic emitter 120 are displayed as a target location on the CT scan”),
capturing position data for a second plurality of registration points along a first lateral region of the head of the patient, the position data for the second plurality of registration points being captured based on signals from the position sensor of the registration probe as the registration probe is positioned at each registration point of the second plurality of registration points (corresponding disclosure in at least [0026] and Figure 3, where the system is capable of detecting registration points when the patient is positioned on the second lateral side of the head, where multiple points along the region are being registered using the registration point “Referring back to step 220 of method 200, Target T1M corresponds to a first point on the patient's face touched by the operator, target T2M corresponds to a second point on the patient's face touched by the operator, and target T3M corresponds to a third point on the patient's face touched by the operator. A number of nasal cavities 310 can also be seen in the image S as depicted in FIG. 3. Also shown in FIG. 3 are targets T1, T2, and T3 (shown as dashed crosshairs). These targets represent the actual location of the probe 110 in three-dimensional space”)
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Figure 3 of Govari
and registering a real-time position of the patient based on at least the captured position data for the first plurality of registration points and the captured position data for the second plurality of registration points (corresponding disclosure in at least [0034], where the registration of the real-time position of the patient is based on captured position data via the probe “ A physician monitoring the convergence of the probe 110 in real time on the image, (e.g., CT scan), may determine that a sufficient amount of the patient's face has been registered Alternatively, a mathematical algorithm, such as a minimum mean square error (MMSE) algorithm may be utilized to determine when enough of a patient's face has been registered”).
Govari does not teach an image guided surgery system.
Palushi, in a similar field of endeavor, teaches a similar concept (imaging via registration probe) of an image guided surgery system (corresponding disclosure in at least [0032], where the real-time position of the patient is used with an image guided surgery system “Such displayed images may also include graphical representations of instruments that are inserted in the patient's head (H), such as navigation guidewire (40), such that the operator may view the virtual rendering of the instrument at its actual location in real time”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of an image guided surgery system based on the captured position data to achieve registration of the patient with the image guided surgery system as taught by Palushi. One of the ordinary skill in the art would have been motivated to incorporate this because the registration steps are used prior to procedures for more accurate surgical navigation.
Regarding Claim 4, Govari and Palushi teach the limitations of Claim 1 and Govari further teaches the face of the head of the patient has skin, and capturing position data for the first plurality of registration points comprises contacting the skin with the registration probe at the first plurality of registration points (corresponding disclosure in at least [0023], where the registration probe works by touching the probe to the patient’s face “the operator touches registration probe 110 to an area of the patient's face depicted in the display 150 of FIG. 1”, and further in [0038], where it’s specified that the patient does have skin “ hovers on the surface of the skin with a matching impedance such as a gel, and leaves a gel trace”).
Regarding Claim 11, Govari and Palushi teach the limitations of Claim 1 and Govari further teaches driving a display to visually indicate to an operator locations of the first plurality of registration points along a face of the head of the patient; and driving the display to visually indicate to the operator locations of the second plurality of registration points along the first lateral region of the head of the patient (corresponding disclosure in at least [0020] and Figure 1, where the plurality of points along the face of the patient and lateral region are displayed “The workstation 140 is also connected to the display 150. The driver 160 is connected to the magnetic emitter 120 to emit one or more magnetic fields and frequencies around a patient's head H. As can be seen on the display 150, an image S is displayed that has a target T on it. The target T indicates a current location of the registration probe 110 in space with respect to head H”).
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Figure 1 of Govari
Regarding Claim 12, Govari and Palushi teach the limitations of Claim 1 and Govari further teaches wherein driving the display to visually indicate to the operator locations of the first plurality of registration points comprises rendering a first set of indicators on the display; and driving the display to visually indicate to the operator locations of the second plurality of registration points comprises rendering a second set of indicators on the display (corresponding disclosure in at least [0020], where the display visualizes the registration points, rendering indicators “As can be seen on the display 150, an image S is displayed that has a target T on it. The target T indicates a current location of the registration probe 110 in space with respect to head H. An operator can then see the target on the image S and register areas of the patient's face on the image S for later use in an ENT procedure”, where the indicated multiple areas are saved, meaning there are indicators for the areas and further in [0026], where the indicators are described “FIG. 3 is an example facial image for use during the facial registration method of FIG. 2. For purposes of example, the facial image in FIG. 3 may be image S from FIG. 1. As can be seen in FIG. 3, targets T (designated T1M, T2M, and T3M are shown as solid crosshairs”).
Regarding Claim 13, Govari and Palushi teach the limitations of Claim 12 and Govari further teaches displaying a three-dimensional rendering of the head of the patient, wherein: rendering the first set of indicators on the display comprises overlaying the first set of indicators on the three-dimensional rendering of the head of the patient; and rendering the second set of indicators on the display comprises overlaying the second set of indicators on the three-dimensional rendering of the head of the patient (corresponding disclosure in at least [0036] and Figure 7, where there is a 3D rendering of the head of the patient, which has the first and second set of indicators overlaying the head “. These targets represent the targets that would be registered in a conventional magnetic modality registration method, such as method 200 described above. Targets T1, T2, and T3 represent the actual location of the probe 110 in three-dimensional space. It can therefore be seen then that an ENT procedure performed utilizing the correlated target locations acquired in method 600 would be performed in a correct area with relation to the nasal cavities 310 as compared to performing the procedure utilizing the target areas acquired in the conventional method”).
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Figure 7 of Govari
Regarding Claim 16, Govari and Palushi teach the limitations of Claim 1, and Palushi further teaches receiving a signal from a position sensor of a medical instrument, wherein: the medical instrument is disposed in the head of the patient, and the signal from the position sensor of the medical instrument indicates a real-time position of the position sensor of the medical instrument in three-dimensional space (corresponding disclosure in at least [0031], where there is a position sensor of a medical instrument (the guidewire) which is disposed within the head of the patient “This phenomenon may enable IGS navigation system (10) to determine the location of the distal end of navigation guidewire (40) or other medical instrument (e.g., dilation instrument, surgical cutting instrument, etc.) within a three-dimensional space (i.e., within the head (H) of the patient (P), etc.). To accomplish this, processor (12) executes an algorithm to calculate location coordinates of the distal end of navigation guidewire (40) from the position related signals of the coil(s) in navigation guidewire (40). While the position sensor is located in guidewire” and further in [0037], where the position is tracked in 3D space “ This tracked space (300) is a three-dimensional space of varying sizes and shapes and may include at least the space in which the surgical procedure is performed”).
Regarding Claim 17, Govari and Palushi teach the limitations of Claim 16, and Palushi further teaches wherein the signal from the position sensor of the medical instrument indicates a real-time position of a distal end of the medical instrument in three-dimensional space (corresponding disclosure in at least [0031], where the sensor determines the distal end location “This phenomenon may enable IGS navigation system (10) to determine the location of the distal end of navigation guidewire (40) or other medical instrument (e.g., dilation instrument, surgical cutting instrument, etc.) within a three-dimensional space (i.e., within the head (H) of the patient (P), etc.)” and further in [0032], where the position is shown in real-time “Processor (12) is further operable to provide video in real time via display screen (16), showing the position of the distal end of navigation guidewire”).
Regarding Claim 18, Govari and Palushi teach the limitations of Claim 16, and Palushi further teaches determining the real-time position of a portion of the medical instrument relative to the real-time position of the patient and further relative to a corresponding position in one or more preoperative images, based on at least the registration of the patient with the image guided surgery system and the signal from the position sensor of the medical instrument (corresponding disclosure in at least [0040], where a medical instrument portion is shown in real-time relative to a patient corresponding disclosure in at least to a preoperative image based on registration The suction tool (200) includes a position sensor (202) that allows the position of distal tip (204) to be tracked by the IGS navigation system (10) within the tracked space (300), and positionally displayed in real time within the virtual view and preoperatively obtained images of the patient's anatomy to aid in precise placement and use during a surgical procedure” and further in [0039], where the information is registered “As each point is registered, the position sensor (106) provides that location, within the tracked space (300), to the IGS navigation system (10), which may use such information to correlate the position of any tracked surgical instruments with the patient's position”).
Regarding Claim 19, Govari and Palushi teach the limitations of Claim 18, and Palushi further teaches driving a display to render an indicator showing a real-time position of a portion of the medical instrument in relation to the one or more preoperative images (corresponding disclosure in at least [0032], where the medical instrument portion has an indicator real-time in the image “Such displayed images may also include graphical representations of instruments that are inserted in the patient's head (H), such as navigation guidewire (40), such that the operator may view the virtual rendering of the instrument at its actual location in real time”).
Regarding Claim 20, Govari and Palushi teach the limitations of Claim 18, and Palushi further teaches the one or more preoperative images comprising one or both of a CT scan image of the patient or a three-dimensional model of the patient (corresponding disclosure in at least [0032], where a CT scan image is used “a CT scan image of the patient's head (H), and/or a computer generated three-dimensional model of the anatomy within and adjacent to the patient's nasal cavity”).
the medical instrument being inserted into the head of the patient via an ear of the patient on the first lateral side of the head of the patient.
Claims 2-3 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US20190046155A1) in view of Palushi (US20200188031A1) as applied in Claim 1, and in further view of Govari (US20210174522A1).
Regarding Claim 2, Govari and Palushi teach the limitations of Claim 1 and the capture of position data for the first plurality of registration point, but does not specify wherein the head of the patient has a posterior region, and the head of the patient is supported on the posterior region.
Govari, in a similar field of endeavor, teaches a similar concept (image registration) of wherein the head of the patient has a posterior region, and the head of the patient is supported on the posterior region (corresponding disclosure in at least [0028] and Figure 1, where the posterior region of the head is supported; the head is immobile and supported by the bed “typically applicable if patient 14 is anesthetized and has a recumbent immobile head 38 on a bed 40, generators 36, as illustrated in FIG. 1, are fixed to a frame 42 placed on the bed, beside the patient's head”).
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Figure 1 of Govari
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the posterior region of the head being supported as taught by Govari. One of the ordinary skill in the art would have been motivated to incorporate this because the support ensures the head of the patient to not move as registration is being completed.
Regarding Claim 3, Govari and Palushi teach the limitations of Claim 1 and the head of the patient has a second lateral region opposite to the first lateral region and capture of position data for the second plurality of registration points, but does not specify the head of the patient is supported on the second lateral region.
Govari, in a similar field of endeavor, teaches a similar concept (image registration) of wherein the head of the patient is supported on the second lateral region (corresponding disclosure in at least [0028] and Figure 1, where the posterior region of the head is supported; the head is immobile and supported by the bed “typically applicable if patient 14 is anesthetized and has a recumbent immobile head 38 on a bed 40, generators 36, as illustrated in FIG. 1, are fixed to a frame 42 placed on the bed, beside the patient's head”, where the system, or the bed, is capable of supporting the second lateral region of the patient head i.e. the patient’s head is turned on its side, as the patient position of head orientation has no effect on the structure).
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Figure 1 of Govari
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the posterior region of the head being supported as taught by Govari. One of the ordinary skill in the art would have been motivated to incorporate this because the support ensures the head of the patient to not move as registration is being completed.
Regarding Claim 14, Govari and Palushi teach the limitations of Claim 1, but do not teach receiving a patient tracking signal from a tracking sensor, wherein: the tracking sensor is fixedly secured to the head of the patient, and the patient tracking signal indicates a real-time position of the head of the patient.
Govari, in a similar field of endeavor, teaches a similar concept of receiving a patient tracking signal from a tracking sensor, wherein: the tracking sensor is fixedly secured to the head of the patient, and the patient tracking signal indicates a real-time position of the head of the patient (corresponding disclosure in at least Figure 1 and [0028], where there is a sensor secured to the patient for tracking “A three-axis reference coil 41 is fixed to head 38, and connected to processing unit 26 by a cable”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a tracking sensor attached to the head of the patient for real-time position tracking as taught by Govari. One of the ordinary skill in the art would have been motivated to incorporate this because knowing the position of the head of the patient provides as a reference point for the other sensors/trackers.
Regarding Claim 15, the combined references noted above teach the limitations of Claim 14, and Govari further teaches registering the real-time position of the patient with the image guided surgery system is further based on the patient tracking signal (Corresponding disclosure in at least [0028], where the information is sent to the unit for registration “In order to track the instruments referred to above within patient 14, as well as to track probe 16, processing unit 26 uses probe tracking module 28 to operate, via a cable 35, a plurality of magnetic field generators 36, such as coils”).
Claims 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US20190046155A1) in view of Palushi (US20200188031A1) as applied to in claim 1, and Bai (US20220039876A1).
Regarding Claim 5, Govari and Palsuhi teach the limitations of Claim 1 and wherein the lateral region of the head of the patient has skin ([0038] of Govari) and capturing position data for the first plurality of registration points ([0020] of Govari), but does not teach forming a flap in the skin of the patient in the lateral region of the head of the patient;
and peeling the flap away from the head of the patient;
wherein capturing position data for the first plurality of registration points comprises contacting the head of the patient in a region from which the flap was peeled away.
Bai, in a similar field of endeavor, teaches a similar concept (surgical navigation) of forming a flap in the skin of the patient in the lateral region of the head of the patient and peeling the flap away from the head of the patient;
(corresponding disclosure in at least [0057], where a dura flap, or a flap in the skin, is formed and peeled away (retracted) “A craniotomy is performed; and a dura flap is formed and retracted”) and contacting the head of the patient in a region from which the flap was peeled away (corresponding disclosure in at least [0097], where there is a pointing tool which contacts the exposed part of the head where the flap was peeled away “such suction tool may be advantageously fitted with one or more cameras and/or pressure sensors, as noted above, to improve inner cavity assessment while using the tracked suction tool. Much like the pointing tool described herein, the suction tool comprises a sensored tip, e.g., laterally oriented sensors operatively mounted on an axially or opposing laterally directed suction tool”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated forming a flap in the skin of the patient and contacting the head of the patient in the peeled region for position data as taught by Bai. One of the ordinary skill in the art would have been motivated to incorporate this because peeling the skin flap away from the patient is an essential step in certain surgical procedures to access a portion of the bone of the patient.
Regarding Claim 6, the combined references above teach the limitations of Claim 5, and Bai further teaches wherein forming the flap in the skin of the patient comprises forming the flap in a periosteal region of the head of the patient (corresponding disclosure in at least [0057], where a dura flap is formed, which is an outer region that covers the periosteal region “A craniotomy is performed; and a dura flap is formed and retracted”).
Regarding Claim 7, the combined references above teach the limitations of Claim 5, and Bai further teaches peeling the flap away from the head of the patient results in exposure of bone of the head of the patient (corresponding disclosure in at least [0057], where a dura flap is formed, which exposes the bone of the patient “A craniotomy is performed; and a dura flap is formed and retracted”).
Regarding Claim 8, the combined references above teach the limitations of Claim 7, and Bai further teaches wherein the exposed bone comprises temporal bone (corresponding disclosure in at least [0057] and Figure 1, where a dura flap is formed, which would expose the bone/skull, and Figure 1 shows the temporal portion of the head being exposed “A craniotomy is performed; and a dura flap is formed and retracted”).
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Figure 1 of Bai
Regarding Claim 9, the combined references above teach the limitations of Claim 7, and Bai further teaches further comprising clearing additional soft tissue away from the bone (corresponding disclosure in at least [0039], where a suction tool is used in the surgical cavity, which clears soft tissues around the surgical area (the bone) “ the surgical tool further comprises a suction tool at or proximal to said tip to concurrently provide suction within the surgical cavity around said tip, and the surgical cavity is externally visible to an external camera aligned therewith”).
Regarding Claim 10, the combined references above teach the limitations of Claim 7, and further teaches wherein capturing position data for the second plurality of registration points along the first lateral region of the head of the patient (corresponding disclosure in at least [0026] and Figure 3 of Gavori) comprises contacting the bone with the registration probe (corresponding disclosure in at least [0058] of Bai, where there is a registration probe (OCT probe) for tracking purposes, which is used surgically (contacts the bone) “other sensored or non-sensored intraoperative surgical tools, such as, but not limited to, inner-cavity pointing tools, suction tools, tissue probes, e.g., Raman, OCT probes, etc., resection tools and the like, are also advantageously tracked by the tracking system to enhance accuracy and precision of executed operative procedures.”).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Cappadona (US20190183589A1) and Palushi (US20200188031A1) as applied to in claim 16, and in further view of Makower (US20070208252A1).
Regarding Claim 21, Cappadona and Palsuhi teach the limitations of Claim 16 and the medical instrument being inserted into the head of the patient ([0156] of Cappadona) but does not teach the medical instrument being inserted via an ear of the patient on the first lateral side of the head of the patient.
Makower, in the same field of endeavor, teaches a similar concept (surgical navigation), of the medical instrument being inserted via an ear of the patient on the first lateral side of the head of the patient (corresponding disclosure in at least [0022], where the instrument would be inserted via the ear, which would be located on either lateral side of the head of a patient “ there is provided a system that is useable to perform a procedure in which a working device is inserted to a position within an ear, nose, throat or paranasal sinus of a human or animal subject”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated inserting the medical instrument via an ear of the patient as taught by Makower. One of the ordinary skill in the art would have been motivated to incorporate this because insertion via the ear allows direct access for any treatment or diagnosis necessary within the ear.
Response to Arguments
Applicant’s arguments filed 02/24/2026 in regards to the Claim objections have been withdrawn in light of the amendments.
Applicant’s arguments, see pages 9-14, filed 02/24/2026, with respect to the rejection(s) of claim(s) 1-21 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Govari and Palushi (see office action above). Govari teaches within the field of image registration using a registration probe.
Conclusion
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/K.E.K./Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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