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
Applicant’s amendments filed 01/08/2026 have been entered. Claim 1-5, 11-13, 16-17, 19-20, 25-31, 34, and 42-43 are pending and currently under consideration for patentability under 37 CFR 1.104. Response to arguments found below.
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.
Claim(s) 1-5, 11-13, 16-17, 19, 25-30, 34, and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. (U.S. 2019/0298451) in view of McDowall et al. (U.S. 2019/0090960).
Wong et al. incorporates U.S. Pat. No. 6,380,732 to Gilboa at paragraph [0024].
With respect to claim 1, Wong et al. teaches a method of performing a medical procedure at a targeted site in a small intestine of a patient, the method comprising:
imaging a patient's duodenum and jejunum with an imaging system (para [0037] and [0053] teach an initial model can be made from a CT scan while para [0056] teaches creating a model of the duodenum, jejunum, and/or the ileum);
displaying a virtual image of a duodenum and a jejunum of the patient on a display screen (340, para [0041] see also para [0057]);
introducing an endoscope with an image sensor (226, para [0030],[0033]) having a forward-oriented field of view (FIG. 2A) into the patient's duodenum (FIG. 6) wherein the image sensor is at the distal tip of the endoscope (para [0030]);
utilizing a sensor system (localization sensor, para [0026]) wherein the sensor system comprises a sensing array (24 of Gilboa) and a sensor component (206b, para [0026], see also 30 of Gilboa), wherein the sensor component is on an outer surface of a sensor sleeve (206b on outer surface of 216, FIG. 2b) where the sensor sleeve is separate from the sensing array (FIG. 1 of Gilboa for example) and is carried by the endoscope proximal to the image sensor (para [0030]) wherein the sensor component functions to spatially locate the endoscope (para [0026]-[0027]), wherein the sensor sleeve is disposable independent from the image sensor (216 is separate from 226)
displaying a location of the endoscope in the virtual image (para [0049]) of the patient's duodenum on the display screen (para [0056])
advancing a treatment tool into the patient's duodenum (para [0061]);
displaying the location of the treatment tool (para [0027]) in the virtual image (para [0037]) of the patient's duodenum on the display screen (para [0056]); and
positioning treatment tool proximate the targeted site and actuating the treatment tool to perform the medical procedure (para [0051]-[0052], see also para [0056]-[0063]).
That is, Wong et al. provides a detailed explanation of the method of FIG. 3 with respect to elongate device 202 and then provides a specific example of performing the method in the duodenum with respect to elongate device 702. Wong et al. does not repeat every aspect of the method as it applies to device 702 however it would be obvious to one of ordinary skill in the art that all of the details discussed with respect to FIG. 3 also apply to the device 702 because Wong et al. states, “to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless specifically described otherwise” at paragraph [0017].
However, Wong does not teach positioning a sensing array at an exterior of a patient’s body, wherein the sensing array sends an interrogation signal from the sensing array to a sensor component, wherein the sensor component responds to the interrogation signal by sending a location signal to the sensing array to spatially locate the endoscope.
With respect to claim 1, McDowall et al. teaches a method for performing a medical procedure at a targeted site in a patient, the method comprising:
positioning a sensing array (86) at an exterior of a patient’s body (FIG. 2, 3), wherein the sensing array sends an interrogation signal from the sensing array to a sensor component (para [0034]-[0036]), wherein the sensor component is incorporated into a tubular member (82, para [0034]) wherein the tubular member is sperate from the sensing array (FIG. 2, 3) wherein the sensor component responds to the interrogation signal by sending a location signal to the sensing array to spatially locate the endoscope (para [0036]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the sensor array of Wong to use the transceiver pad as taught by McDowall et al. in order to reduce the three-dimensional footprint of the sensing array (FIG. 1 of Gilboa vs FIG. 2,3 of McDowall et al.).
With respect to claim 2, Wong et al. teaches the imaging system includes at least one of magnetic resonance imaging (MRI), computed tomography (CT), ultrasonography, positron emission tomography (PET), x-ray imaging and endoscopic imaging (para [0053],[0056]).
With respect to claim 3, Wong et al. teaches the virtual image comprises displaying at least a portion of each of a stomach, pylorus, duodenum and jejunum on the display screen (FIG. 6).
With respect to claim 4, Wong et al. teaches displaying a real image from an endoscope image sensor of an endoscope on a display screen (para [0037],see also para [0066]).
With respect to claim 5, Wong et al. teaches moving the endoscope and a treatment tool in small intestine in response to observing at least one of the virtual image and the real image (para [0050]).
With respect to claim 11, Wong et al. teaches the treatment tool is adapted for movement between a first retracted position within a distal portion of the endoscope and a second extended position extending distally from the endoscope (medical instrument slidably disposed within the main lumen of the elongate device para [0028]).
With respect to claim 12, Wong et al. teaches the treatment tool comprises a catheter (704) adapted to be advanced through a working channel in the endoscope (para [0061]).
With respect to claim 13, Wong et al. teaches the treatment tool includes an energy delivery system (ablation probe, para [0052]) for applying energy to a wall of the duodenum (all or a portion of the duodenal mucosal tissue can be ablated para [0054]).
With respect to claim 16, Wong et al. teaches applying energy comprises at least one of a thermal heating treatment or a cryogenic treatment (para [0062]).
With respect to claim 17, Wong et al. teaches the energy delivery system provides a heated flowable media (heated vapor para [0062]) to apply energy to the wall of the duodenum.
With respect to claim 19, Wong et al. teaches the heated flowable media applies energy to a mucosa directly or conductively through a balloon wall (para [0062]).
With respect to claim 25, Wong et al. teaches a method of providing a virtual image of a region of a small intestines of a patient, the method comprising:
introducing an endoscope (702/202) with an image sensor (230, para [0029]) having a forward-oriented field of view (FIG. 2A) into s a lumen of a patient's small intestine (FIG. 6) wherein the image sensor is at a distal tip of the endoscope (para [0029]-[0030]);
utilizing a sensor system (localization sensor, para [0026]) wherein the sensor system comprises a sensing array (24 of Gilboa) and a sensor component (206b, para [0026], see also 30 of Gilboa), wherein the sensor component is on an outer surface of a sensor sleeve (206b on outer surface of 216, FIG. 2b) where the sensor sleeve is separate from the sensing array (FIG. 1 of Gilboa for example) and is carried by the endoscope proximal to the image sensor (para [0030]) wherein the sensor component functions to spatially locate the endoscope (para [0026]-[0027]), wherein the sensor sleeve is disposable independent from the image sensor (216 is separate from 226); and
processing the location signal with a processor to generate a virtual image of the small intestine on a display screen (para [0049],[0056]).
That is, Wong et al. provides a detailed explanation of the method of FIG. 3 with respect to elongate device 202 and then provides a specific example of performing the method in the duodenum with respect to elongate device 702. Wong et al. does not repeat every aspect of the method as it applies to device 702 however it would be obvious to one of ordinary skill in the art that all of the details discussed with respect to FIG. 3 also apply to the device 702 because Wong et al. states, “to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless specifically described otherwise” at paragraph [0017].
However, Wong does not teach positioning a sensing array at an exterior of a patient’s body, wherein the sensing array sends an interrogation signal from the sensing array to a sensor component, wherein the sensor component responds to the interrogation signal by sending a location signal to the sensing array to spatially locate the endoscope.
With respect to claim 25, McDowall et al. teaches a method for performing a medical procedure at a targeted site in a patient, the method comprising:
positioning a sensing array (86) at an exterior of a patient’s body (FIG. 2, 3), wherein the sensing array sends an interrogation signal from the sensing array to a sensor component (para [0034]-[0036]), wherein the sensor component is incorporated into a tubular member (82, para [0034]) wherein the tubular member is sperate from the sensing array (FIG. 2, 3) wherein the sensor component responds to the interrogation signal by sending a location signal to the sensing array to spatially locate a three-dimensional location of the endoscope (para [0036]-[0037]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the sensor array of Wong to use the transceiver pad as taught by McDowall et al. in order to reduce the three-dimensional footprint of the sensing array (FIG. 1 of Gilboa vs FIG. 2,3 of McDowall et al.).
With respect to claim 26, Wong et al. teaches a method of performing a medical procedure at a targeted site in an intestinal tract of a patient, the method comprising:
introducing an endoscope (702/202) with an image sensor (230, para [0029]) having a forward-oriented field of view (FIG. 2A) into a lumen of a patient's intestine (FIG. 6) wherein the image sensor is at a distal tip of the endoscope (para [0029]-[0030]);
utilizing a sensor system (localization sensor, para [0026]) wherein the sensor system comprises a sensing array (24 of Gilboa) and a sensor component (206b, para [0026], see also 30 of Gilboa), wherein the sensor component is on an outer surface of a sensor sleeve (206b on outer surface of 216, FIG. 2b) where the sensor sleeve is separate from the sensing array (FIG. 1 of Gilboa for example) and is carried by the endoscope proximal to the image sensor (para [0030]) wherein the sensor component functions to spatially locate the endoscope (para [0026]-[0027]), wherein the sensor sleeve is disposable independent from the image sensor (216 is separate from 226) ;
processing the location signal with a processor to display a virtual model of the lumen on a display screen (para [0049],[0056]); and
advancing a treatment tool in the lumen (para [0061]);
utilizing the sensor system to display a location of the treatment tool (para [0027]) in the virtual model (para [0037]) of the lumen on the display screen (para [0056]); and
displaying the location of the treatment tool (para [0027]) in the virtual image (para [0037]) of the patient's duodenum on the display screen (para [0056]); and
tracking the location of the treatment tool on the display screen to position the treatment tool at the targeted site to perform the medical procedure at a treatment site (para [0050]).
That is, Wong et al. provides a detailed explanation of the method of FIG. 3 with respect to elongate device 202 and then provides a specific example of performing the method in the duodenum with respect to elongate device 702. Wong et al. does not repeat every aspect of the method as it applies to device 702 however it would be obvious to one of ordinary skill in the art that all of the details discussed with respect to FIG. 3 also apply to the device 702 because Wong et al. states, “to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless specifically described otherwise” at paragraph [0017].
However, Wong does not teach positioning a sensing array at an exterior of a patient’s body, wherein the sensing array sends an interrogation signal from the sensing array to a sensor component, wherein the sensor component responds to the interrogation signal by sending a location signal to the sensing array to spatially locate the endoscope.
With respect to claim 26, McDowall et al. teaches a method for performing a medical procedure at a targeted site in a patient, the method comprising:
positioning a sensing array (86) at an exterior of a patient’s body (FIG. 2, 3), wherein the sensing array sends an interrogation signal from the sensing array to a sensor component (para [0034]-[0036]), wherein the sensor component is incorporated into a tubular member (82, para [0034]) wherein the tubular member is sperate from the sensing array (FIG. 2, 3) wherein the sensor component responds to the interrogation signal by sending a location signal to the sensing array to spatially locate the endoscope (para [0036]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the sensor array of Wong to use the transceiver pad as taught by McDowall et al. in order to reduce the three-dimensional footprint of the sensing array (FIG. 1 of Gilboa vs FIG. 2,3 of McDowall et al.).
With respect to claim 27, Wong et al. teaches utilizing the sensor system (para [0022]) to display the location of the endoscope in the virtual model of the lumen on the display screen (para [0049],[0056]).
With respect to claim 28, Wong et al. teaches a virtual model displays at least a region of a stomach, a pylorus, a duodenum, or a jejunum (para [0056]).
With respect to claim 29, Wong et al. teaches a virtual model displays at least a region of a first part, a second part, a third part, or a fourth part of a duodenum (para [0056]).
With respect to claim 30, Wong et al. teaches a virtual model displays a major papilla (para [0056], FIG. 6).
With respect to claim 34, Wong et al. teaches he image sensor captures images of walls of the lumen and the processor is used to process the images to display an appearance of the walls in the virtual model (para [0037]).
With respect to claim 42, Wong et al. teaches displaying one or more indicators associated with one or more operating parameter of the treatment tool on the display screen (para [0048]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. (U.S. 2019/0298451) in view of McDowall et al. (U.S. 2019/0090960) as applied to claim 17 above and further in view of Hoey et al. (U.S. 9,924,992).
Wong et al. teaches a method as set forth above. While Wong et al. teaches the energy delivery system provides a heated flowable media, Wong et al. does not teach the heated flowable media is heated in a portion of the treatment tool.
With respect to claim 20, Hoey et al. teaches the heated flowable media is heated in a portion of the treatment tool (FIG. 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the energy delivery system of Wong et al. to utilize the energy delivery system of Hoey et al. wherein the heated flowable media is heated in a portion of the treatment tool in order to controllably apply thermal energy in a controlled and localized manner without the lack of control often associated when Rf, laser and microwave energy are applied directly to tissue (1:65-2:2 of Hoey et al.).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. (U.S. 2019/0298451) in view of McDowall et al. 9U.S. 2019/0090960) as applied to claim 26 above and further in view of Kappel et al. (U.S. 2014/0358089).
Wong et al. teaches a method as set forth above. Specifically, Wong et al. teaches any image visualized by the endoscope being incorporated into the virtual model (para [0037]). However, Wong et al. does not explicitly state the virtual model displays a minor papilla.
With respect to claim 31, Kappel et al. teaches an analogous method of imaging the major papilla (para [0024]) that can be applied to the minor papilla as well (para [0022]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Wong et al. to include visualizing and therefore mapping the minor papilla because Kappel et al. teaches it is obvious to try (para [0022] of Kappel et al.).
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. (U.S. 2019/0298451) in view of McDowall et al. (U.S. 2019/0090960) as applied to claim 42 above and further in view of Ladtkow et al. (U.S. 2020/0046435).
Wong et al. teaches a method as set forth above. However, Wong does not teach the display is configured to function as a touchscreen to adjust the one or more operating parameters of the treatment tool.
With respect to claim 43, Ladtkow et al. teaches the display is configured to function as a touchscreen (para [0040]) to adjust the one or more operating parameters of the treatment tool (para [0054]-[0055]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Wong et al. to utilize a touchscreen display configured to adjust the one or more operating parameters of the treatment tool in the manner taught by Ladtkow et al. in order to allow the user to visualize an ablation procedure if one or more parameters of the ablation procedure are changed and determine the optimal parameters for the ablation procedure to be performed (para [0056] of Ladtkow et al.).
Response to Arguments
Applicant's arguments filed 01/08/2026 have been fully considered but they are not persuasive.
On page 7 Applicant argues the alleged image se3nsor of Wong, imaging sensor 230, is embedded within the elongated device 202. This is not persuasive at least because Wong teaches at paragraph [0030] “Alternatively, medical instrument 226 may itself be the image capture probe. Medical instrument 226 may be advanced from the opening of main lumen 204 to perform the procedure and then retracted back into the channel when the procedure is complete. Medical instrument 226 may be removed from a proximal end of flexible body 216 or from another optional instrument port (not shown) along flexible body 216.” Therefore, Wong teaches an alternative embodiment wherein the image sensor is not embedded within the flexible body 216.
Conclusion
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/ALEXANDRA L NEWTON/Primary Examiner, Art Unit 3799