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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3 March 2026 has been entered.
Response to Arguments
Applicant does not explicitly address the objection to Claim 19, mistyped in the objection heading as Claim 20 in the Office Action filed 3 December 2025. Therefore, the objection is maintained as below.
Applicant’s argument on Pages 12-14 regarding the rejection of Claims 1 and 19-20 under 35 U.S.C. 102(a)(1) as being anticipated by Kapoor has been fully considered but is not persuasive under new grounds of rejection as below.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Page 14 relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
Claim Objections
Claims 1 and 19-20 are objected to because of the following informalities: minor error in antecedent basis. The claim should be amended to “[…] an endoscopic surgery, has [[an]] the insertion portion to be inserted […]” in order to establish proper antecedent basis. Appropriate correction is required.
Claim 4 objected to because of the following informalities: minor error in antecedent basis. The claim should be amended to “[…] to change [[a]] the position and [[a]] the posture of the insertion portion […]” in order to establish proper antecedent basis. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: minor grammatical error. It is suggested the claim be amended to “[…] the operation method comprising: [[via the process,]] acquiring […]” in order to make sense grammatically. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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, 6, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kronman (US 20170119474) in view of Craig et al. (US 11529038).
Regarding Claims 1 and 20, Kronman teaches a medical support device, communicably connected to a medical device, an extracorporeal camera, and a display, (Figs. 1A and 1B, [0067] “System 100 may include a multi-viewing elements endoscope 102,” and [0069] “the main control unit 199 comprises a screen/display 120”), comprising:
a) a processor, ([0068] “Main Control Unit 199” and [0088] “main controller 142”), wherein the processor is configured to:
i) acquire a captured image that is captured by the extracorporeal camera provided outside a body of a subject, (Fig. 1B and [0088] “Optical tracker, or external camera 148, is placed above the patient 134 so that the camera 148 captures the endoscope 140, fiducial markers 146 and the patient's body 134 in the same image 150”), wherein the medical device has an insertion portion that is inserted into the body of the subject, (Fig. 1B and [0087] “endoscope 140”), and a marker, ([0088] “A plurality of fiducial markers 146 are provided on the endoscope 140.”), wherein the marker is provided at a grip portion of the medical device and is at a position visible from the outside of the body of the subject, (Fig. 1B), wherein the marker is included in an imaging range of the extracorporeal camera ([0088] “Optical tracker, or external camera 148, is placed above the patient 134 so that the camera 148 captures the endoscope 140, fiducial markers 146 and the patient's body 134 in the same image 150”);
ii) derive position and posture information including at least one of a position or a posture of the insertion portion of the medical device in the captured image based on the marker ([0064] “the orientation of the endoscope obtained from the fiducial markers and the bending, turning, or orientation information obtained via the sensors together provides a precise orientation of the entire endoscope within the patient” and [0095]-[0096] “At step 302, a reference position of the endoscope within a patient's body is determined either in the scope's coordinate system (internal) or an external coordinate system. […] to determine a position of the scope within a patient's body using the scope's coordinate system, fiducial markers are placed on the handle of the endoscope.”); and
iii) execute a control of displaying, on the display, a composite image in which medical support information is superimposed at a position specified in the captured image based on the position and posture information, (Fig. 1B, [0003] “The present specification relates generally to endoscopes, and more specifically, to a device and method for displaying an image of a position of an endoscope within a patient's body, […] overlaid on an image of the patient's body,” and [0088] “Optical tracker, or external camera 148, is placed above the patient 134 so that the camera 148 captures the endoscope 140, fiducial markers 146 and the patient's body 134 in the same image 150 displayed on an external display unit 152.”),
iv) wherein the medical device is used for an endoscopic surgery, ([0059] “The endoscope can then perform diagnostic or surgical procedures inside the body cavity.”), has an insertion portion to be inserted into the body from a hole formed in a body surface of the subject on a distal end side, (Fig. 1B, [0047] “It is noted that the term “endoscope” as mentioned herein may refer particularly to a colonoscope, according to some embodiments, but is not limited only to colonoscopes. The term “endoscope” may refer to any instrument used to examine the interior of a hollow organ or cavity of the body”), and has the marker provided on a proximal end side, (Fig. 1B), and
v) wherein the processor derives the position and posture information of the distal end side of the medical device based on the marker provided on the proximal end side of the medical device ([0095]-[0096] “At step 302, a reference position of the endoscope within a patient's body is determined either in the scope's coordinate system (internal) or an external coordinate system. […] to determine a position of the scope within a patient's body using the scope's coordinate system, fiducial markers are placed on the handle of the endoscope.”).
Furthermore, the cited actions are computer implemented, which necessitate associated computer-readable media, as in [0029] (“computing unit”).
However, Kronman does not explicitly teach wherein the processor derives the position and posture information of the distal end side of the medical device based on dimensional information of the medical device.
In an analogous endoscope with inertial measurement units field of endeavor, Craig teaches a medical support device, (Claim 22 “endoscope system”), wherein the processor, (Claim 22 “computer”), derives the position and posture information of the distal end side of the medical device based on dimensional information of the medical device (Claim 22 “a computer configured for facilitating handling properties of the endoscope […] as a response to position and orientation data received from the one or more distal IMUs and intermediate IMUs, the position and orientation data including bend length, angle of bend, and distance from prior bend.”).
Furthermore, the cited actions are computer implemented, which necessitate associated computer-readable media, as in Column 8 Lines 8-11 (“The computer 16 may comprise a processor and a computer-readable storage medium that stores instructions that when executed by the processor, carry out the functions attributed to the computer 16 as described herein.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Kronman with the processor of Craig because the modification enhances navigation within the patient’s body.
Regarding Claim 4, the modified device of Kronman teaches all limitations of Claim 1, as discussed above. Furthermore, Craig teaches wherein, in a case where the medical device is configured to change a position and a posture of the insertion portion by operating an operation portion provided outside the body, the processor is configured to acquire an operation amount of the operation portion in addition to the dimensional information, and the acquired operation amount is used for deriving the position and posture information of the insertion portion (Column 5 Lines 12-17 “One or more manually operable controllers, i.e. haptic input devices 43 are located on handle 40 for providing force feedback while inputting electronic commands for manipulating endoscope physical properties, i.e. for steering and/or adjusting the torsional and bending stiffness characteristics of insertion tube 20.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Kronman with the processor of Craig for the same reasons as Claim 1.
Regarding Claim 6, the modified device of Kronman teaches all limitations of Claim 1, as discussed above. Furthermore, Kronman teaches wherein the medical device is a medical probe that is configured to observe an internal structure of an organ ([0004] “An endoscope is a medical instrument used for examining and treating internal body cavities such as the alimentary canals, airways, the gastrointestinal system, and other organ systems” and [0006] “Some endoscopes have viewing elements for viewing an internal organ, such as the colon, and an illuminator for illuminating the field of view of the viewing elements.”).
Regarding Claim 19, Kronman teaches an operation method of a medical support device, (Abstract “Systems and methods of tracking the position of an endoscope within a patient's body during an endoscopic procedure”), including a processor, ([0068] “Main Control Unit 199” and [0088] “main controller 142”), the medical support device communicably connected to a medical device, an extracorporeal camera, and a display, (Figs. 1A and 1B, [0067] “System 100 may include a multi-viewing elements endoscope 102,” and [0069] “the main control unit 199 comprises a screen/display 120”), the operation method comprising:
via the process,
a) acquiring a captured image that is captured by the extracorporeal camera provided outside a body of a subject, (Fig. 1B and [0088] “Optical tracker, or external camera 148, is placed above the patient 134 so that the camera 148 captures the endoscope 140, fiducial markers 146 and the patient's body 134 in the same image 150”), wherein the medical device has an insertion portion that is inserted into the body of the subject, (Fig. 1B and [0087] “endoscope 140”), and a marker, ([0088] “A plurality of fiducial markers 146 are provided on the endoscope 140.”), wherein the marker is provided at a grip portion of the medical device and is at a position visible from the outside of the body of the subject, (Fig. 1B), wherein the marker is included in an imaging range of the extracorporeal camera ([0088] “Optical tracker, or external camera 148, is placed above the patient 134 so that the camera 148 captures the endoscope 140, fiducial markers 146 and the patient's body 134 in the same image 150”);
b) deriving position and posture information including at least one of a position or a posture of the insertion portion of the medical device in the captured image based on the marker ([0064] “the orientation of the endoscope obtained from the fiducial markers and the bending, turning, or orientation information obtained via the sensors together provides a precise orientation of the entire endoscope within the patient” and [0095]-[0096] “At step 302, a reference position of the endoscope within a patient's body is determined either in the scope's coordinate system (internal) or an external coordinate system. […] to determine a position of the scope within a patient's body using the scope's coordinate system, fiducial markers are placed on the handle of the endoscope.”); and
c) executing a control of displaying, on the display, a composite image in which medical support information is superimposed at a position specified in the captured image based on the position and posture information, (Fig. 1B, [0003] “The present specification relates generally to endoscopes, and more specifically, to a device and method for displaying an image of a position of an endoscope within a patient's body, […] overlaid on an image of the patient's body,” and [0088] “Optical tracker, or external camera 148, is placed above the patient 134 so that the camera 148 captures the endoscope 140, fiducial markers 146 and the patient's body 134 in the same image 150 displayed on an external display unit 152.”),
d) wherein the medical device is used for an endoscopic surgery, ([0059] “The endoscope can then perform diagnostic or surgical procedures inside the body cavity.”), has an insertion portion to be inserted into the body from a hole formed in a body surface of the subject on a distal end side, (Fig. 1B, [0047] “It is noted that the term “endoscope” as mentioned herein may refer particularly to a colonoscope, according to some embodiments, but is not limited only to colonoscopes. The term “endoscope” may refer to any instrument used to examine the interior of a hollow organ or cavity of the body”), and has the marker provided on a proximal end side, (Fig. 1B), and
e) wherein the position and posture information of the distal end side of the medical device is derived based on the marker provided on the proximal end side of the medical device ([0095]-[0096] “At step 302, a reference position of the endoscope within a patient's body is determined either in the scope's coordinate system (internal) or an external coordinate system. […] to determine a position of the scope within a patient's body using the scope's coordinate system, fiducial markers are placed on the handle of the endoscope.”).
However, Kronman does not explicitly teach wherein the processor derives the position and posture information of the distal end side of the medical device based on dimensional information of the medical device.
In an analogous endoscope with inertial measurement units field of endeavor, Craig teaches an operation method of a medical support device, (Column 1 Lines 16-17 “The present disclosure relates generally to endoscopes and associated systems and methods” and Claim 22 “endoscope system”), including a processor, (Claim 22 “computer”), the operation method comprising: via the process, deriving the position and posture information of the distal end side of the medical device based on dimensional information of the medical device (Claim 22 “a computer configured for facilitating handling properties of the endoscope […] as a response to position and orientation data received from the one or more distal IMUs and intermediate IMUs, the position and orientation data including bend length, angle of bend, and distance from prior bend.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Kronman with the processor of Craig because the modification enhances navigation within the patient’s body.
Regarding Claim 21, the modified device of Kronman teaches all limitations of Claim 1, as discussed above. Furthermore, Kronman teaches wherein the extracorporeal camera is an optical camera ([0088] “Optical tracker, or external camera 148”).
Claims 5, 7-9, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kronman (US 20170119474) in view of Craig et al. (US 11529038), as applied to Claim 1, further in view of Neishi et al. (US 20210030510).
Regarding Claim 5, the modified device of Kronman teaches all limitations of Claim 1, as discussed above. However, the modified device of Kronman does not explicitly teach wherein the medical device is a first medical device having an intracorporeal camera for imaging the inside of the body, and in a case where the insertion portion of the first medical device is set as a first insertion portion, the marker of the first medical device is set as a first marker, the captured image is set as a first captured image, and the position and posture information is set as first position and posture information, and further, a second medical device, which is different from the first medical device, is communicably connected to the medical support device, and is provided with a second insertion portion to be inserted into the body and a second marker that is image-recognizable in the second insertion portion, is used for surgery together with the first medical device, the processor is configured to: acquire a second captured image which is captured by the intracorporeal camera, wherein the second insertion portion and the second marker are included in an imaging range of the intracorporeal camera; derive second position and posture information including at least one of a position or a posture of the second insertion portion in the second captured image based on the second marker; and execute a control of displaying, on the display, a composite image in which the medical support information is superimposed on the first captured image at a position specified in the first captured image based on the first position and posture information and the second position and posture information.
In an analogous surgical field of endeavor, Neishi teaches a medical support device, ([0041] “endoscopic surgery system 5000”), wherein
a) wherein the medical device is a first medical device having an intracorporeal camera for imaging the inside of the body, ([0045] “The endoscope 5001 includes […] a camera head 5005” and [0076] “the communication unit 230 receives the image of the biological organ from the surgical camera 10.”), and
b) in a case where the insertion portion of the first medical device is set as a first insertion portion, (Fig. 1 and [0042] “the abdominal wall is punctured with a plurality of tubular piercing devices referred to as trocars 5025a to 5025d in place of incision of the abdominal wall”), the marker of the first medical device is set as a first marker, the captured image is set as a first captured image, and the position and posture information is set as first position and posture information, ([0057] “The position measurement apparatus 6000 measures positions and/or postures of a tool, which is to be used in the endoscopic surgery such as the endoscope 5001” and [0099] “First, the device marker 6001 for the measurement of the position and the posture is attached to the surgical camera 10, and the position measurement apparatus 6000 measures the position of the device marker 6001 (S210).”), and
c) further, a second medical device, which is different from the first medical device, is communicably connected to the medical support device, (Fig. 1), and is provided with a second insertion portion to be inserted into the body and a second marker that is image-recognizable in the second insertion portion, is used for surgery together with the first medical device, (Fig. 1 and [0068] “The device marker 6001 may be attached to, for example, any of the surgical tools 5017.” Where one of ordinary skill in the art would understand that multiple device markers 6001 may be used in order to track multiple surgical tools 5017 at one time.),
d) the processor is configured to:
i) acquire a second captured image, ([0080] “the image processing unit 210 occasionally acquires images of the biological organ from the surgical camera 10”), which is captured by the intracorporeal camera, wherein the second insertion portion and the second marker are included in an imaging range of the intracorporeal camera (Fig. 1);
ii) derive second position and posture information including at least one of a position or a posture of the second insertion portion in the second captured image based on the second marker ([0057] “The position measurement apparatus 6000 measures positions and/or postures of a tool, which is to be used in the endoscopic surgery such as the endoscope 5001” and [0099] “First, the device marker 6001 for the measurement of the position and the posture is attached to the surgical camera 10, and the position measurement apparatus 6000 measures the position of the device marker 6001 (S210).”); and
iii) execute a control of displaying, on the display, a composite image in which the medical support information is superimposed on the first captured image at a position specified in the first captured image based on the first position and posture information and the second position and posture information (Fig. 4 and [0083] “a position and a range of the region A may be displayed on the second image. For example, a scale along the first direction may be displayed as illustrated in FIG. 4. The display of the position and the range of the region A is not limited to display of a scale, and it is sufficient if the user perceives the position and the range of the region A. For example, coordinate values or the like of the region A may be displayed” and [0094] “The image processing unit 210 then calculates changes in the positions and the shapes of the biological organ and the element tissue that occur during surgery, and updates the superimposition image being displayed on the display apparatus 5041.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Neishi because the modification allows for both internal and external validation of location of any devices within the subject, ensuring an accurate and efficient procedure.
Regarding Claim 7, the modified device of Kronman teaches all limitations of Claim 5, as discussed above. Furthermore, Neishi teaches wherein
a) the first medical device is an endoscope, ([0041] “endoscope 5001”), and
b) the second medical device is a medical probe that is configured to observe an internal structure of an organ ([0042] “trocars 5025a to 5025d,” [0042] surgical tools 5017 are merely examples” and [0057] “The three-dimensional information of element tissue includes […] an ultrasonograph image of element tissue such as a blood vessel, a nervous plexus, a lymphatic vessel, or a tumor of the patient 5071.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Neishi because the modification allows for both internal and external validation of location of any devices within the subject, ensuring an accurate and efficient procedure.
Regarding Claim 8, the modified device of Kronman teaches all limitations of Claim 6, as discussed above. Furthermore, Neishi teaches wherein the medical support information is insertion support information of a treatment tool that is inserted from outside the body toward a target position in the organ observed through the medical probe, ([0042] “the abdominal wall is punctured with a plurality of tubular piercing devices referred to as trocars 5025a to 5025d in place of incision of the abdominal wall to perform laparotomy. Then, a lens barrel 5003 of the endoscope 5001 and the other surgical tools 5017 are inserted into body cavity of the patient 5071 through the trocars 5025a to 5025d.”), and is the insertion support information including at least one of an insertion position, ([0057] “The position measurement apparatus 6000 measures positions and/or postures of a tool, which is to be used in the endoscopic surgery such as the endoscope 5001 or the surgical tools 5017, and the patient.”), or an insertion route.
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Neishi because the modification allows for an operator to observe the interior of a biological body, rather than directly checking the area with unaided eyes, as taught by Neishi in [0002]. Additionally, deriving the exact position and posture information of the inserted medical device ensures minimal damage to the patient and an accurate imaging procedure.
Regarding Claim 9, the modified device of Kronman teaches all limitations of Claim 8, as discussed above. Furthermore, Neishi teaches wherein the medical probe is an ultrasound probe ([0041] “endoscope 5001,” where it is understood that the endoscope is an ultrasound probe.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Neishi because the modification includes the general advantages of utilizing an endoscope, such as minimal invasiveness, quick procedure, and quick recovery of the patient.
Regarding Claim 14, the modified device of Kronman teaches all limitations of Claim 8, as discussed above. Furthermore, Neishi teaches wherein the processor is configured to specify a position at which the insertion support information is superimposed on the captured image based on the target position specified in an internal image of the organ acquired by the medical probe, (Fig. 4 and [0086] “the position of the region A may be determined in accordance with a position of a predetermined surgical tool 5017.”), and a correlation between a coordinate system of the internal image and a coordinate system of the captured image which are derived based on the position and posture information ([0096] “the control unit 220 reflects the acquired three-dimensional distribution information of the element tissue in the image of the biological organ acquired by the surgical camera 10 and registers the information with the image (S153). […] the endoscopic surgery system 5000 sets the surgical camera distal end coordinate system 6003 illustrated in FIG. 1 with respect to the measured position and the measured posture of the surgical camera 10.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Neishi because the modification ensures accuracy of treatment with insertion of tools into the patient.
Regarding Claim 15, the modified device of Kronman teaches all limitations of Claim 7, as discussed above. Furthermore, Neishi teaches wherein
a) the medical support information is insertion support information of a treatment tool that is inserted from outside the body toward a target position in the organ observed through the medical probe, ([0042] “the abdominal wall is punctured with a plurality of tubular piercing devices referred to as trocars 5025a to 5025d in place of incision of the abdominal wall to perform laparotomy. Then, a lens barrel 5003 of the endoscope 5001 and the other surgical tools 5017 are inserted into body cavity of the patient 5071 through the trocars 5025a to 5025d.”), and is the insertion support information including at least one of an insertion position, ([0057] “The position measurement apparatus 6000 measures positions and/or postures of a tool, which is to be used in the endoscopic surgery such as the endoscope 5001 or the surgical tools 5017, and the patient.”), or an insertion route,
b) in a case where the insertion support information is set in a three-dimensional image of the organ acquired in advance before surgery by simulation before the surgery, ([0057] “The three-dimensional information of element tissue includes a CT (Computed Tomography) image, an MRI (Magnetic Resonance Imaging) image, or an ultrasonograph image of element tissue such as a blood vessel, a nervous plexus, a lymphatic vessel, or a tumor of the patient 5071.” Where it would be obvious to one of ordinary skill in the art that the three-dimensional information of element tissue may be acquired pre-operatively via a simulation and/or modeling software.), and
c) the processor is configured to superimpose the insertion support information on the first captured image using a correlation between a coordinate system of an internal image of the organ acquired by the medical probe and a coordinate system of the three-dimensional image, ([0073] “The image processor 20 according to the present embodiment specifies element tissue included in a three-dimensional region being a portion of the biological organ on the basis of three-dimensional distribution information of element tissue included in the biological organ, and superimposes and displays the specified element tissue on the image acquired by the surgical camera 10.”), and a correlation between a coordinate system of the internal image and a coordinate system in the second captured image which are derived based on the second position and posture information ([0096] “the control unit 220 reflects the acquired three-dimensional distribution information of the element tissue in the image of the biological organ acquired by the surgical camera 10 and registers the information with the image (S153). […] the endoscopic surgery system 5000 sets the surgical camera distal end coordinate system 6003 illustrated in FIG. 1 with respect to the measured position and the measured posture of the surgical camera 10.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Neishi because the modification allows for an operator to observe the interior of a biological body, rather than directly checking the area with unaided eyes, as taught by Neishi in [0002]. Additionally, deriving the exact position and posture information of the inserted medical device ensures minimal damage to the patient and an accurate imaging procedure.
Claims 10-12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kronman (US 20170119474) in view of Craig et al. (US 11529038), as applied to Claim 1, further in view of Breisacher et al. (US 20140243658).
Regarding Claim 10, the modified device of Kronman teaches all limitations of Claim 8, as discussed above. However, the modified device of Kronman does not explicitly teach wherein the treatment tool is a puncture needle.
In an analogous calculation of a position of a surgical device field of endeavor, Breisacher teaches a medical support device, ([0064] “surgical device”), wherein the treatment tool is a puncture needle ([0064] “needle-like instrument 150” and Fig. 3).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings Breisacher because the modification allows for the operator to take a biopsy at a dedicated target point, as taught by Breisacher in [0073].
Regarding Claim 11, the modified device of Kronman teaches all limitations of Claim 10, as discussed above. Furthermore, Breisacher teaches wherein the insertion position is displayed by a mark indicating a position on the body surface of the subject at which the puncture needle is inserted ([0074] “As soon as the camera 160 can localize the marking 170 on the ultrasound probe 140 in relation to the instrument 150 itself, the system 100 calculates the relative position (and, optionally, its orientation) between the instrument 150 and the imaged patient region and, based on that position, overlays a calculated trajectory of the proximal end 152 of the instrument 150 and an intersection point of the trajectory and the image plane 142 on the displayed ultrasound image. In FIG. 4, the calculated trajectory is visualized by a dashed line, and the intersection point is indicated by a circle. Also, the projection of the current position of the proximal end 152 of the instrument 150 is visualized,” [0076] “Of course, the visual feedback based on the positional and orientational relationship between the ultrasound probe 140 and the instrument 150 can also be a three-dimensional visualization. Moreover, any other feedback (e.g., sound, display of measurements, etc.) which gives the surgeon information how to correct the current position or orientation of the instrument 150 to hit the target point may be provided” and [0087] “The projector 165 may be used to project a visualization of the image data taken by the ultrasound probe 140 or by any other imaging device on the patient's body.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Breisacher because the modification allows for the operator to take a biopsy at a dedicated target point, as taught by Breisacher in [0073].
Regarding Claim 12, the modified device of Kronman teaches all limitations of Claim 10, as discussed above. Furthermore, Breisacher teaches wherein the insertion route is indicated by a line (Fig. 4 and [0062] “The computer assistant guidance may, for example, comprise displaying the patient image and the position of the surgical device (or its projection, its trajectory, or its projected trajectory, as calculated from the position) on the display device 120.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the teachings of with Breisacher because the modification allows for the operator to take a biopsy at a dedicated target point, as taught by Breisacher in [0073].
Regarding Claim 17, the modified device of Kronman teaches all limitations of Claim 16, as discussed above. Furthermore, Breisacher teaches wherein the treatment tool is a puncture needle, ([0064] “needle-like instrument 150” and Fig. 3), and an imaging optical axis of the extracorporeal camera is disposed along an axial direction of the puncture needle ([0043] “camera 160” and “second camera 160A” and Fig. 3).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Breisacher because the modification allows for direct observation of the region of insertion on the patient (marking 170 of Breisacher), as taught by Breisacher in [0043].
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kronman (US 20170119474) in view of Craig et al. (US 11529038) and Neishi et al. (US 20210030510), as applied to Claim 7, further in view of Sasady et al. (US 20170065250).
Regarding Claim 13, the modified device of Kronman teaches all limitations of Claim 7, as discussed above. However, the modified device of Kronman does not explicitly teach wherein the medical support information is insertion support information of a treatment tool that is inserted from outside the body toward a target position in the organ observed through the medical probe, and is the insertion support information including at least one of an insertion position or an insertion route, the medical probe is provided in the insertion portion and has a guide groove for guiding insertion of the treatment tool into the target position by engaging with the treatment tool, and the processor is configured to specify a position at which the insertion support information is superimposed on the captured image based on a relative positional relationship between the second marker and the guide groove.
In an analogous ultrasound imaging field of endeavor, Sasady teaches a medical device, ([0029] “imaging system 102”), wherein
a) the medical support information is insertion support information of a treatment tool that is inserted from outside the body toward a target position in the organ observed through the medical probe, and is the insertion support information including at least one of an insertion position or an insertion route, ([0066]-[0067] “At 1812, a camera in the cavity acquires data showing the illuminated region and depressions from the pressing. At 1814, an instrument insertion point is identified in response to a depression coinciding with the illuminated region.”),
b) the medical probe is provided in the insertion portion, (Fig. 17), and has a guide groove for guiding insertion of the treatment tool into the target position by engaging with the treatment tool, ([0042] “The instrument guide 142 includes a material free region or slot 402. The slot 402 is configured to allow an instrument to pass through the instrument guide 142.”), and
c) the processor is configured to specify a position at which the insertion support information is superimposed on the captured image based on a relative positional relationship between the second marker and the guide groove ([0070] “At 1820, the instrument is advanced in the instrument guide 142 to the structure of interest, under guidance of the instrument guide and image data and/or other guidance.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Sasady because the modification allows for the instrument (needle) to pass through the instrument guide directly to the region of interest, as taught by Sasady in [0042].
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kronman (US 20170119474) in view of Craig et al. (US 11529038) and Neishi et al. (US 20210030510), as applied to Claim 8, further in view of Marti (US 20220087753).
Regarding Claim 16, the modified device of Kronman teaches all limitations of Claim 8, as discussed above. However, the modified device of Kronman does not explicitly teach wherein the extracorporeal camera is provided on a proximal end side of the treatment tool and is configured to output the captured image as a video image, and the processor is configured to display a line indicating the insertion route in the video image as the insertion support information.
In an analogous reciprocal optical tracking field of endeavor, Marti teaches a medical support device, ([0049] “computer-assisted surgical system (CASS) 100”), wherein
a) the extracorporeal camera is provided on a proximal end side of the treatment tool, (Fig. 1 and [0055] “Various types of tracking systems may be used in various embodiments of the present invention including […] video or image based tracking systems”), and is configured to output the captured image as a video image, ([0070] “The Display 125 provides graphical user interfaces (GUIs) that display images collected by the Tissue Navigation System 120”), and
b) the processor is configured to display a line indicating the insertion route in the video image as the insertion support information ([0109] “The Surgical Computer 150 provides the Display 125 with any visualization that is needed by the Surgeon 111 during surgery. For monitors, the Surgical Computer 150 may provide instructions for displaying images, GUIs, etc. using techniques known in the art. The display 125 can include various portions of the workflow of a surgical plan. […] The display 125 can include information about the surgical target area. […] Accordingly, the display 125 is an interactive interface that can dynamically update and display how changes to the surgical plan would impact the procedure and the final position and orientation of implants installed on bone.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Marti because the modification provides real-time support during the procedure for the operator, which minimizes the chances of error.
Regarding Claim 18, the modified device of Kronman teaches all limitations of Claim 8, as discussed above. Furthermore, Kronman teaches wherein the processor further acquires at least two captured images captured by the extracorporeal camera from different viewpoints, (Fig. 1B and [0025] “the endoscope system comprises two stereo-calibrated cameras adapted to generate second orientation data comprising 3D location of the fiducials in the cameras' own coordinate system by triangulation.”)
Moreover, Marti teaches wherein the processor is configured to derive the insertion position on the body surface of the subject by obtaining an intersection of the insertion routes shown in the two captured images ([0055] “The Tracking System 115 uses one or more sensors to collect real-time position data that locates the patient's anatomy and surgical instruments. […] In addition to positional data, data from the Tracking System 115 also can be used to infer velocity/acceleration of anatomy/instrumentation”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Marti because the modification ensures accuracy of locale of the treatment while also keeping elements of the system to a minimum, e.g., the insertion portion does not need to be provided with trackable sensors.
Conclusion
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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