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 .
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0034] of Applicant’s specification, “in greater detail elbow” should read “in greater detail below”
Appropriate correction is required.
Claim Objections
Claims 4 and 5 are objected to because of the following informalities:
In claim 4, lines 1-2, “a low withdrawal speed anomaly” should read “the low withdrawal speed anomaly”. This suggested modification would eliminate a potential 112(b) rejection.
In claim 5, lines 1-2, “a high withdrawal speed anomaly” should read “the high withdrawal speed anomaly.” This suggested modification would eliminate a potential 112(b) rejection.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 7, and 9-17 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.
Claims 2, 7, and 9-15 recite the limitation "the balloon" in l. 5 of claim 2, l. 4 of claim 7, l. 5 and 7 of claim 9, l. 2 of claim 10, l. 2 of claim 11, l. 5 and 7 of claim 12, l. 2 of claim 13, l. 2 of claim 14, and l. 5 and 7 of claim 15. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the balloon” is being interpreted as “the inflatable balloon.”
Claims 16-17 are rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
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.
Claims 1, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0164186 A1 to Terliuc et al. (“Terliuc”) in view of U.S. Patent Appl. Publ. No. 2014/0220527 A1 to Li et al. (“Li”).
Regarding claim 1, Terliuc discloses a system (endoscope system 102; Fig. 1, paragraph 0120) comprising:
a balloon endoscope comprising a visualization element (an endoscope 100 having a CCD 101 at the forward end thereof; Fig. 2A, paragraph 0120) and an inflatable balloon (inflatable/deflatable balloon 110; Fig. 2A, paragraph 0122), wherein the balloon endoscope is configured to mechanically enhance visualization of tissue when moved within an intestinal lumen of a patient with the inflatable balloon inflated to a sub-anchoring pressure (the slidable frictional engagement pressure is selected to cause the balloon, when inflated and displaced to enhance visual contrast between polyps and other potential and actual pathologies and the interior wall; Fig. 5A-D, paragraph 0011), the inflatable balloon causing axial stretching of tissue of the intestinal lumen to at least partially flatten or unfold natural topography of the tissue (inflating and thus anchoring the endoscope tool balloon 314 in the colon; thereafter pushing the endoscope tool balloon 314 forwardly, thereby stretching the colon to enable enhanced viewing of the interior of the colon with reduced folds; and visually inspecting the stretched portion of the colon; Figs. 7, paragraphs 0202-0205 and 0231); and
a computing device comprising one or more processors and computer-readable memory (computerized controller 402, such as a suitably programmed microcontroller; Fig. 12, paragraph 0243), the computing device programmed by executable instructions to at least:
obtain an image of a portion of the tissue using the visualization element (monitor 304 shows an image of a portion of the colon forward of CCD 301; Fig. 10, paragraph 0239).
However, Terliuc does not explicitly disclose the computing device programmed by executable instructions to at least:
analyze the image using a machine learning model trained to generate classification output data representing a procedure anomaly classification;
determine, based at least partly on the classification output data, that the image corresponds to a procedure anomaly;
generate feedback data based on the procedure anomaly, wherein the feedback data represents a remedial action to be taken with respect to the balloon endoscope; and
send the feedback data to at least one of a user interface subsystem or a control subsystem.
Li teaches a system for machine-learning-based analysis of an endoscopy procedure (a video-based skill coaching system; paragraph 0037), the system comprising:
a computing device comprising one or more processors (a processor in the system may be employed to process the captured streams in real-time; paragraph 0046), the computing device programmed by executable instructions to at least:
analyze the image using a machine learning model trained to generate classification output data representing a procedure anomaly classification (the system is aimed at providing automated feedback that has the following three features: (i) specific (locating where the errors and defects are); paragraphs 0037 and 0046);
determine, based at least partly on the classification output data, that the image corresponds to a procedure anomaly (the system is aimed at providing automated feedback that has the following three features: (i) specific (locating where the errors and defects are); paragraphs 0037 and 0046);
generate feedback data based on the procedure anomaly, wherein the feedback data represents a remedial action to be taken with respect to the balloon endoscope (the system is aimed at providing automated feedback that has the following three features … (ii) instructive (explaining why they are defects and how to improve); paragraph 0037); and
send the feedback data to at least one of a user interface subsystem or a control subsystem (feedback window 304 provides real-time feedback, such as operation speed, jitter, and the number of errors made in the current training session; Fig. 3, paragraph 0406). Li teaches the use of the system for improving training of endoscopic procedures.
Li is considered to be analogous to the claimed invention because it is in the same field of endoscope systems with a computer- implemented system for detecting procedure anomalies. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Terliuc to incorporate the teachings of Li by utilizing a machine-learning analysis of an endoscope procedure to identify procedure anomalies and notify the user. Doing so helps to improve the user’s performance of the procedure, as recognized by Li.
Regarding claim 18, Terliuc, as previously modified by Li, discloses the system according to claim 1. Li further teaches wherein the computing device is programmed by further executable instructions to obtain a second image using the visualization element, analyze the second image using the machine learning model to generate second classification output data, determine, based at least partly on the second classification output data, that the second image corresponds to no procedure anomaly, and cause presentation of a message regarding remediation of the procedure anomaly (the system may allow a user to compare performance against a reference video… after analyzing the user’s performance using the algorithms described in detail below, the system will provide feedback such as skill level 502, comments 504, and allow the user to simultaneously view the user’s performance and the reference video in windows 506, 508; Fig. 5, paragraph 0051) (feedback window 304 provides real-time feedback, such as operation speed, jitter, and the number of errors made in the current training session; paragraph 0046).
Regarding claim 20, Terliuc, as previously modified by Li, discloses the system according to claim 1. Li further teaches wherein the procedure anomaly is one of a plurality of procedure anomalies that the computing device is configured to detect using the machine learning model (the system is aimed at providing automated feedback that has the following three features: (i) specific (locating where the errors and defects are); paragraphs 0037 and 0046).
Claims 2, 7, and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Li as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2017/0251917 A1 to Reydel (“Reydel”).
Regarding claim 2, Terliuc, as previously modified by Li, discloses the system according to claim 1. However, Terliuc, as modified by Li, does not explicitly disclose wherein the computing device is programmed by further executable instructions to:
determine, based at least partly on the procedure anomaly being one of an under- inflation anomaly or an over-inflation anomaly, that the remedial action comprises a change to an inflation pressure of the balloon; and
display, on a user interface, a message indicating a manner in which the inflation pressure is to be changed.
Reydel teaches wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly being one of an under- inflation anomaly or an over-inflation anomaly, that the remedial action comprises a change to an inflation pressure of the balloon and display, on a user interface, a message indicating a manner in which the inflation pressure is to be changed (the pressure monitoring feature may also include a transmission mechanism to relay the pressure measurements from the pressure sensor to an informing feature, such as but not limited to a display or an alarm … if a display is included as part of an informing feature, the pressure measurements may be visually presented to the practitioner. If an alarm is included as part of an informing feature, a noise may be emitted when the balloon pressure exceeds or dips below predetermined threshold levels. The practitioner may then adjust the pressure using a manual or automated system; paragraph 0149). Reyel teaches that the pressure monitoring feature helps to reduce the risk of overinflating or rupturing the balloon within the patient (paragraph 0149).
Reyel is considered to be analogous to the claimed invention because it is in the same field of endoscope systems with an inflatable balloon. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Terliuc, as modified by Li, to incorporate the teachings of Reyel by detecting an under-inflation anomaly or an over-inflation anomaly and notifying the user. Doing so helps to reduce the risk of overinflating or rupturing the balloon within the patient, as recognized by Reyel.
Regarding claim 7, Terliuc, as previously modified by Li, discloses the system according to claim 1. However, Terliuc, as modified by Li, does not explicitly disclose wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly comprising an under- inflation anomaly, that inflation of the balloon is to be confirmed and display, on a user interface, a message indicating inflation of the balloon is to be confirmed.
Reydel teaches wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly comprising an under- inflation anomaly, that inflation of the balloon is to be confirmed and display, on a user interface, a message indicating inflation of the balloon is to be confirmed (the pressure monitoring feature may also include a transmission mechanism to relay the pressure measurements from the pressure sensor to an informing feature, such as but not limited to a display or an alarm … if a display is included as part of an informing feature, the pressure measurements may be visually presented to the practitioner. If an alarm is included as part of an informing feature, a noise may be emitted when the balloon pressure exceeds or dips below predetermined threshold levels. The practitioner may then adjust the pressure using a manual or automated system; paragraph 0149). Reyel teaches that the pressure monitoring feature helps to reduce the risk of overinflating or rupturing the balloon within the patient (paragraph 0149).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Terliuc, as modified by Li, to incorporate the teachings of Reyel by detecting an under-inflation anomaly and notifying the user. Doing so helps to reduce the risk of overinflating or rupturing the balloon within the patient, as recognized by Reyel.
Regarding claim 9, Terliuc, as previously modified by Li, discloses the system according to claim 1. However, Terliuc, as modified by Li, does not explicitly disclose wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly being one of an over- inflation anomaly or a low withdrawal speed anomaly, that the remedial action comprises a reduction in an inflation pressure of the balloon; and generate a command for the control subsystem to reduce the inflation pressure of the balloon.
Reydel teaches wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly being one of an over- inflation anomaly or a low withdrawal speed anomaly, that the remedial action comprises a reduction in an inflation pressure of the balloon; and generate a command for the control subsystem to reduce the inflation pressure of the balloon (the pressure monitoring feature may also include a transmission mechanism to relay the pressure measurements from the pressure sensor to an informing feature, such as but not limited to a display or an alarm … if a display is included as part of an informing feature, the pressure measurements may be visually presented to the practitioner. If an alarm is included as part of an informing feature, a noise may be emitted when the balloon pressure exceeds or dips below predetermined threshold levels. The practitioner may then adjust the pressure using a manual or automated system; paragraph 0149). Reyel teaches that the pressure monitoring feature helps to reduce the risk of overinflating or rupturing the balloon within the patient (paragraph 0149).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Terliuc, as modified by Li, to incorporate the teachings of Reyel by detecting an over-inflation anomaly and notifying the user. Doing so helps to reduce the risk of overinflating or rupturing the balloon within the patient, as recognized by Reyel.
Regarding claim 10, Terliuc, as previously modified by Li and Reyel, discloses the system according to claims 1 and 9. Reyel further teaches wherein to reduce the inflation pressure of the balloon, the command causes the control subsystem to switch the inflation pressure of the balloon to a lower pressure level (If an alarm is included as part of an informing feature, a noise may be emitted when the balloon pressure exceeds or dips below predetermined threshold levels. The practitioner may then adjust the pressure using a manual or automated system; paragraph 0149).
Regarding claim 11, Terliuc, as previously modified by Li and Reyel, discloses the system according to claims 1 and 9. Reyel further teaches wherein to reduce the inflation pressure of the balloon, the command causes the control subsystem to tune the inflation pressure of the balloon to a lower target pressure metric within a pressure range of a particular pressure level (If an alarm is included as part of an informing feature, a noise may be emitted when the balloon pressure exceeds or dips below predetermined threshold levels. The practitioner may then adjust the pressure using a manual or automated system; paragraph 0149).
Regarding claim 12, Terliuc, as previously modified by Li, discloses the system according to claim 1. However, Terliuc, as modified by Li, does not explicitly disclose wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly being one of an under- inflation anomaly or a high withdrawal speed anomaly, that the remedial action comprises an increase in an inflation pressure of the balloon and generate a command for the control subsystem to increase the inflation pressure of the balloon.
Reyel teaches wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly being one of an under- inflation anomaly or a high withdrawal speed anomaly, that the remedial action comprises an increase in an inflation pressure of the balloon and generate a command for the control subsystem to increase the inflation pressure of the balloon (the pressure monitoring feature may also include a transmission mechanism to relay the pressure measurements from the pressure sensor to an informing feature, such as but not limited to a display or an alarm … if a display is included as part of an informing feature, the pressure measurements may be visually presented to the practitioner. If an alarm is included as part of an informing feature, a noise may be emitted when the balloon pressure exceeds or dips below predetermined threshold levels. The practitioner may then adjust the pressure using a manual or automated system; paragraph 0149). Reyel teaches that the pressure monitoring feature helps to reduce the risk of overinflating or rupturing the balloon within the patient (paragraph 0149).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Terliuc, as modified by Li, to incorporate the teachings of Reyel by detecting an under-inflation anomaly and notifying the user. Doing so helps to reduce the risk of overinflating or rupturing the balloon within the patient, as recognized by Reyel.
Regarding claim 13, Terliuc, as previously modified by Li and Reyel, discloses the system according to claims 1 and 12. Reyel further teaches wherein to increase the inflation pressure of the balloon, the command causes the control subsystem to switch the inflation pressure of the balloon to a higher pressure level (If an alarm is included as part of an informing feature, a noise may be emitted when the balloon pressure exceeds or dips below predetermined threshold levels. The practitioner may then adjust the pressure using a manual or automated system; paragraph 0149).
Regarding claim 14, Terliuc, as previously modified by Li and Reyel, discloses the system according to claims 1 and 12. Reyel further teaches wherein to increase the inflation pressure of the balloon, the command causes the control subsystem to tune the inflation pressure of the balloon to a higher target pressure metric within a pressure range of a certain pressure level If an alarm is included as part of an informing feature, a noise may be emitted when the balloon pressure exceeds or dips below predetermined threshold levels. The practitioner may then adjust the pressure using a manual or automated system; paragraph 0149).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Li as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2012/0253204 A1 to Ben-yehuda (“Ben-yehuda”).
Regarding claim 3, Terliuc, as previously modified by Li, discloses the system according to claim 1. However, Terliuc, as modified by Li, does not explicitly disclose wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly being one of a low withdrawal speed anomaly or a high withdrawal speed anomaly, that the remedial action comprises a change to a withdrawal speed of the balloon endoscope and display, on a user interface, a message indicating a manner in which the withdrawal speed is to be changed.
Ben-yehuda teaches wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly being one of a low withdrawal speed anomaly or a high withdrawal speed anomaly, that the remedial action comprises a change to a withdrawal speed of the balloon endoscope and display, on a user interface, a message indicating a manner in which the withdrawal speed is to be changed (the phototherapeutic device includes the speed measurement component, and provides an indication to a physician at what speed to withdraw the phototherapeutic device so that a correct dose is applied to the rectal wall ... The speed indication may optionally be provided as a form of two or three indicators communicating “faster”, “slower”, or “just right” to a physician; paragraph 0080). Ben-yehuda teaches that correct withdrawal speeds helps to ensure a correct dose of treatment is applied to the patient’s tissue (paragraph 0080).
Ben-yehuda is considered to be analogous to the claimed invention because it is in the same field of endoscope systems with an inflatable balloon. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Terliuc, as modified by Li, to incorporate the teachings of Ben-yehuda by detecting a withdrawal speed anomaly and notifying the user. Doing so helps to ensure a correct dose of treatment is applied to the patient’s tissue, as recognized by Ben-yehuda.
Regarding claim 4, Terliuc, as previously modified by Li and Ben-yehuda, discloses the system according to claims 1 and 3. Ben-yehuda further teaches wherein the procedure anomaly comprises a low withdrawal speed anomaly and the manner in which the withdrawal speed is to be changed comprises an increase in the withdrawal speed (the phototherapeutic device includes the speed measurement component, and provides an indication to a physician at what speed to withdraw the phototherapeutic device so that a correct dose is applied to the rectal wall ... The speed indication may optionally be provided as a form of two or three indicators communicating “faster”, “slower”, or “just right” to a physician; paragraph 0080).
Regarding claim 5, Terliuc, as previously modified by Li and Ben-yehuda, discloses the system according to claims 1 and 3. Ben-yehuda further teaches wherein the procedure anomaly comprises a high withdrawal speed anomaly and the manner in which the withdrawal speed is to be changed comprises a reduction in the withdrawal speed (the phototherapeutic device includes the speed measurement component, and provides an indication to a physician at what speed to withdraw the phototherapeutic device so that a correct dose is applied to the rectal wall ... The speed indication may optionally be provided as a form of two or three indicators communicating “faster”, “slower”, or “just right” to a physician; paragraph 0080).
Claims 6 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Li as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2024/0296560 A1 to Cherubini et al. (“Cherubini”).
Regarding claim 6, Terliuc, as previously modified by Li, discloses the system according to claim 1. However, Terliuc, as modified by Li, does not explicitly disclose wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly comprising detection of a tissue anomaly, that the remedial action comprises stopping withdrawal of the balloon endoscope and display, on a user interface, a message indicating withdrawal of the balloon endoscope is to be stopped.
Cherubini teaches wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly comprising detection of a tissue anomaly, that the remedial action comprises stopping withdrawal of the balloon endoscope and display, on a user interface, a message indicating withdrawal of the balloon endoscope is to be stopped (the object of interest may include at least one of a formation on or of human tissue, a change in human tissue from one type of cell to another type of cell, an absence of a human tissue from a location where the human tissue is expected, or a lesion. By way of example, the object of interest may be a polyp. The information for the identified medical guideline may include an instruction to leave or resect the object of interest; paragraph 0009). It is understood to one of ordinary skill in the art to stop withdrawal of the endoscope when performing a treatment such as resection. Cherubini teaches the use of a processor to detect an object of interest helps to ensure proper diagnosis and treatment (paragraph 0003).
Cherubini is considered to be analogous to the claimed invention because it is in the same field of endoscope systems with a computer- implemented system for processing real-time video. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Terliuc, as modified by Li, to incorporate the teachings of Cherubini by detecting a tissue anomaly and notifying the user. Doing so helps to ensure proper diagnosis and treatment, as recognized by Cherubini.
Regarding claim 19, Terliuc, as previously modified by Li, discloses the system according to claim 1. However, Terliuc, as modified by Li, does not explicitly disclose a training computing device comprising one or more processors and computer-readable memory, the training computing device programmed by executable instructions to at least:
obtain a plurality of images;
generate a plurality of training data images using the plurality of images, wherein images in a first subset of the plurality of training data images are associated with label data representing a negative classification for presence of the procedure anomaly, and wherein images in a second subset of the plurality of training data images are associated with label data representing a positive classification for presence of the procedure anomaly;
train the machine learning model using the plurality of training data images; and
distribute the machine learning model to one or more endoscope systems.
Cherubini teaches a training computing device comprising one or more processors and computer-readable memory (the at least one processor of computing device 160 may be configured to apply one or more neural networks that implement a trained characterization network configured to determine a plurality of features associated with the object of interest from the plurality of frames; paragraph 0052 and 0061), the training computing device programmed by executable instructions to at least:
obtain a plurality of images (the characterization network may be trained using a plurality of training frames or portions thereof labeled based on the desired features; paragraph 0061);
generate a plurality of training data images using the plurality of images, wherein images in a first subset of the plurality of training data images are associated with label data representing a negative classification for presence of the procedure anomaly (a second set of training frames (or portions of frames) containing or not containing an object of interest may be labeled as not having the feature; paragraph 0061), and wherein images in a second subset of the plurality of training data images are associated with label data representing a positive classification for presence of the procedure anomaly (a first set of training frames (or portions of frames) containing or not containing an object of interest may be labeled as having a feature; paragraph 0061);
train the machine learning model using the plurality of training data images (the characterization network may be trained using a plurality of training frames or portions thereof labeled based on the desired features; paragraph 0061); and
distribute the machine learning model to one or more endoscope systems (implementations of the above computer-implemented system may include one or more of the following features. The medical procedure may include at least one of endoscopy; paragraph 0012).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Terliuc, as modified by Li, to incorporate the teachings of Cherubini by utilizing sets of labeled images to train the machine learning model, as recognized by Cherubini. It would have been obvious to use any method for training a machine learning model, including the supervised learning in the training of Cherubini. Said combination would amount to use of a known element for its intended use in a known environment to accomplish entirely expected result.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Li as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2024/0252260 A1 to Liu et al. (“Liu”).
Regarding claim 8, Terliuc, as previously modified by Li, discloses the system according to claim 1. However, Terliuc, as modified by Li, does not explicitly disclose wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly comprising a deflection rate anomaly, that the remedial action comprises a reduction in a deflection rate of the balloon endoscope and display, on a user interface, a message indicating that the deflection rate of the balloon endoscope is to be reduced.
Liu teaches wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly comprising a deflection rate anomaly, that the remedial action comprises a reduction in a deflection rate of the balloon endoscope (the correcting device 53b continuously corrects the orientation toward the center through image identification to correct the motion process, which can prevent the tubular component 2 from coming into contact with the inner walls of the patient’s internal cavities; Fig. 10, paragraph 0051). Liu teaches that correcting the deflection rate helps to ensure the safety and reliability of operation (paragraph 0051).
Liu is considered to be analogous to the claimed invention because it is in the same field of endoscope systems with a processor for executing computer programs. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Terliuc, as modified by Li, to incorporate the teachings of Liu by detecting a deflection rate anomaly. Doing so helps to ensure the safety and reliability of operation, as recognized by Liu.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc in view of Li as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2020/0100776 A1 to Blumenkranz et al. (“Blumenkranz”).
Regarding claim 15, Terliuc, as previously modified by Li, discloses the system according to claim 1. However, Terliuc, as modified by Li, does not explicitly disclose wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly comprising a tissue- anomaly-related procedure anomaly, that the remedial action comprises an increase in an inflation pressure of the balloon to an anchoring pressure and generate a command for the control subsystem to increase the inflation pressure of the balloon to the anchoring pressure.
Blumenkranz teaches wherein the computing device is programmed by further executable instructions to determine, based at least partly on the procedure anomaly comprising a tissue- anomaly-related procedure anomaly, that the remedial action comprises an increase in an inflation pressure of the balloon to an anchoring pressure and generate a command for the control subsystem to increase the inflation pressure of the balloon to the anchoring pressure (sealing device 434 may include one or more balloons … in some examples, inflation of the sealing device 434 is … automatically activated in response to the automatic detection of bleeding; Fig. 6, paragraph 0061). Blumenkranz teaches that inflation of the balloon when excess bleeding is detected can help contain the bleeding to those portions of the passageway (paragraph 0061).
Blumenkranz is considered to be analogous to the claimed invention because it is in the same field of endoscope systems with an inflatable balloon. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Terliuc, as modified by Li, to incorporate the teachings of Blumenkranz by detecting a tissue related anomaly and automatically inflating the balloon. Doing so helps to contain the bleeding to those portions of the passageway, as recognized by Blumenkranz.
Regarding claim 16, Terliuc, as previously modified by Li and Blumenkranz, discloses the system according to claims 1 and 15. Blumenkranz further teaches wherein the tissue-anomaly- related procedure anomaly comprises at least one of a tumor, a serious bleeding, a perforation or tear in the tissue, and a serious adverse condition of the tissue (sealing device 434 may include one or more balloons … in some examples, inflation of the sealing device 434 is … automatically activated in response to the automatic detection of bleeding; Fig. 6, paragraph 0061).
Regarding claim 17, Terliuc, as previously modified by Li and Blumenkranz, discloses the system according to claims 1 and 15. Blumenkranz further teaches wherein to generate the command for the control subsystem, the computing device is programmed by further executable instructions to generate a command for a balloon inflation/deflation system (one or more of the processes 905-965 of the method 900 may be implemented, at least in part, in the form of executable code stored on non-transient, tangible, machine readable media that when run by one or more processors (e.g., one or more processors of control system 112) may cause the one or more processers to perform one or more of the processes 904-965; Fig. 9, paragraph 0072).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2022/0248939 A1 to Zubarik et al. teaches a computing device which notified the user when the pressure of the balloon exceeds or falls below a control limit pressure as described in Fig. 6A and the descriptive text.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795