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 .
Election/Restrictions
Applicant’s election, without traverse, of Invention I, directed to claims 1-13, for a medical system, on 07/08/2026, is acknowledged. Claims 14-20 are withdrawn as being directed to a non-elected species. Claims 1-13 are examined below.
Claim Objections
Claims 1-13 are objected to because of the following informalities:
Claims 1-13 use action verbs alone, and in combination with the conjunction, “when,” to describe the function of the processor. Such language is confusing in device claims because it is unclear whether Applicant is trying to claim 1.) multiple steps, 2.) a specific order of steps to describe how the processor operates, or 3.) whether Applicant is merely trying to claim how the processor is configured to function. Examiner respectfully reminds Applicant, that it is not proper for method steps to be in a device claim because such steps renders the claim ambiguous. See MPEP 2173.05(p)(II). Appropriate correction is required for claims 1-13.
For example, claim 1 recites the limitation, “wherein the processor inputs the endoscopic image to the trained model to allow the trained model to detect the treatment tool from the endoscopic image, and acquires, from the trained model, a confidence level as to whether a detected target is the treatment tool, and when the confidence level is equal to or smaller than a predetermined threshold, the processor executes the water supply motion of washing an objective lens of the endoscope.” Such limitation is unclear whether the processor is configured to 1.) perform the three steps (inputs, acquires, and executes), 2.) must complete all three step in the above stated order, or 3.) only perform the three steps when the confidence level is equal to or smaller than a predetermined threshold.
Therefore Examiner respectfully requests Applicant’s to amend the claim language within claims 1-13 to clearly define the meets and bound of Applicant’s intended subject matter by clarifying the function of the processor (as well as memory within claims 9 and 13).
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Moriyama et al. (US8497898) hereinafter Moriyama, in view of Fenech et al. (US10039440) hereinafter Fenech.
Regarding Claim 1, Moriyama discloses a medical system (Figs. 10-12 endoscope system 1C) comprising:
an endoscope (Figs. 10-12 endoscope 2) configured to be electrically driven to move, and to capture an endoscopic image (Figs. 10-12 image from image pickup section 6, Fig. 8 step 11);
a treatment tool (Figs. 10-12 high-frequency instrument 4c) configured to be electrically driven to move;
a processor (Figs. 10-12 processor 7) configured to perform autonomous control of electrically-driven motions of the endoscope and the treatment tool; and
a memory configured to store a trained model trained so as to detect the treatment tool from the endoscopic image showing the treatment tool ([col. 14 lines 8-9] “Initial steps S11 to S18 in FIG. 8 are processes substantially the same as those in steps S1 to S8 in FIG. 4.” And [col. 8 line 64- col 9 line 26] “The sensor section 34 detects the protruding position (from the distal end face of the endoscope 2) of the treatment instrument 4 and outputs the protruding position to the comparison circuit 10 c inside the position determining section 10. That is, as shown in step S2, the position determining section 10 acquires information on the protruding position (protruding amount) of the distal end portion of the treatment instrument 4. As shown in next step S3, the position determining section 10 compares the protruding position of the distal end portion of the treatment instrument 4 with a threshold and determines whether or not the distal end portion of the treatment instrument 4 is located inside the image pickup region. …, when the determination result in step S3 shows that the protruding position of the distal end portion of the treatment instrument 4 is equal to or above the threshold, the position determining section 10 determines that the distal end portion of the treatment instrument 4 is located inside the image pickup region. This determination result is outputted to the low visibility determining section 12.”), wherein
the processor (Figs. 10-12 processor 7) inputs the endoscopic image to the trained model to allow the trained model to detect the treatment tool from the endoscopic image, and acquires, from the trained model, a confidence level as to whether a detected target is the treatment tool(Fig. 4 steps 2-6, Fig. 8 steps 12-16, Figs. 6A-E)), and
While Moriyama does have the processor that is configured to acquire a threshold – confidence level- that is equal to or smaller than a predetermined threshold in Fig. 4 step 8 and Fig. 8 step 19 in the determination to be low visibility, Moriyama only then outputs an alert to the user in a determination result in Fig. 4 step 9 and Fig. 12 step 38, Moriyama fails to specifically disclose the processor executes the water supply motion of washing an objective lens of the endoscope.
However Fenech, in the same field of endeavor teaches, a processor (Fenech – [col. 4 lines 25-31] “The visualization system 110 may be implemented as hardware in combination with firmware or software which interacts with or is otherwise executed by one or more computer processors, which may include the processor(s) of a control system 116.” And [col. 5 lines 8-31] and [col. 13 lines 39 – 58]) configured to control a water-supply motion and obtain a confidence level, and determine when the confidence level is equal to or smaller than a predetermined threshold the processor executes the water supply motion of washing an objective lens of the endoscope (Fenech – Fig. 9 steps 320-328, [col 12 line 19 – col. 13 line 30).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Moriyama with the teachings of Fenech to include a processor configured to control a water-supply motion and obtain a confidence level, and determine when the confidence level is equal to or smaller than a predetermined threshold the processor executes the water supply motion of washing an objective lens of the endoscope for the benefit of having fluid “… be automatically directed towards the operational component in response to detecting a material obstruction of an image” (Fenech – abstract) “…to allow a surgeon to visualize the passageways…” (Fenech – [col. 1 line 20-45) that limits risk to the patient and is less time consuming (Fenech – [col. 1 line 20-45).
Regarding Claim 2, Moriyama in view of Fenech teach the medical system according to claim 1,
While Moriyama does have the processor that is configured to acquire a threshold – confidence level- that is equal to or smaller than a predetermined threshold in Fig. 4 step 8 and Fig. 8 step 19 in the determination to be low visibility, Moriyama only then outputs an alert to the user in a determination result in Fig. 4 step 9 and Fig. 12 step 38, then Moriyama teaches “after the processing in step S9, the process returns to the processing in step S2 and the processing in steps S2 to S9 is repeated.”(Moriyama – [col. 10 lines 13-15]. But Moriyama fails to specifically disclose the processor executes the water supply motion of washing an objective lens of the endoscope.
However Fenech, in the same field of endeavor teaches, a processor (Fenech – [col. 4 lines 25-31] “The visualization system 110 may be implemented as hardware in combination with firmware or software which interacts with or is otherwise executed by one or more computer processors, which may include the processor(s) of a control system 116.” And [col. 5 lines 8-31] and [col. 13 lines 39 – 58]) configured to control a water-supply motion and obtain a confidence level, and determine when the confidence level is equal to or smaller than a predetermined threshold the processor executes the water supply motion of washing an objective lens of the endoscope (Fenech – Fig. 9 steps 320-328, [col 12 line 19 – col. 13 line 30).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Moriyama with the teachings of Fenech to include a processor configured to control a water-supply motion and obtain a confidence level, and determine when the confidence level is equal to or smaller than a predetermined threshold the processor executes the water supply motion of washing an objective lens of the endoscope for the benefit of having fluid “… be automatically directed towards the operational component in response to detecting a material obstruction of an image” (Fenech – abstract) “…to allow a surgeon to visualize the passageways…” (Fenech – [col. 1 line 20-45) that limits risk to the patient and is less time consuming (Fenech – [col. 1 line 20-45).
Regarding Claim 3, Moriyama in view of Fenech teach the medical system according to claim 1, wherein the processor acquires the confidence level again from the trained model after completion of the water supply motion, and when the confidence level acquired again is equal to or smaller than the predetermined threshold, the processor stops the autonomous control (Fenech – step 328).
Regarding Claim 4, Moriyama in view of Fenech teach the medical system according to claim 1, wherein the processor acquires, from the trained model, time-series data of the confidence level corresponding to a time series of the endoscopic image, and when the confidence level is larger than the predetermined threshold over a predetermined period of time after completion of the water supply motion, the processor continues the autonomous control. (Fenech – [col. 13 lines 7-30] “the cleaning routine may be terminated after a predetermined length of time or 15 after a predetermined amount of fluid is dispensed , with or without regard to whether the obstruction has been decreased or removed . In some implementations , a series of two or more automated detect - clean routines is performed until either the system senses that the obstructing matter is 20 carried away or a predetermined number of cleaning routines has been completed , in which case an alternate cleaning method would be required , such as withdrawing the flexible body 214 from the surgical site for manual cleaning . The cleaning system may in some cases output a message on 25 display 111 that advises the surgeon that the automated cleaning process has not been completed or effective.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Moriyama with the teachings of Fenech to include the processor acquires, from the trained model, time-series data of the confidence level corresponding to a time series of the endoscopic image, and when the confidence level is larger than the predetermined threshold over a predetermined period of time after completion of the water supply motion, the processor continues the autonomous control for the benefit of having fluid “… be automatically directed towards the operational component in response to detecting a material obstruction of an image” (Fenech – abstract) “…to allow a surgeon to visualize the passageways…” (Fenech – [col. 1 line 20-45) that limits risk to the patient and is less time consuming (Fenech – [col. 1 line 20-45).
Regarding Claim 5, Moriyama in view of Fenech teach the medical system according to claim 1, wherein the processor acquires, from the trained model, time-series data of the confidence level corresponding to a time series of the endoscopic image, and when the confidence level is equal to or smaller than the predetermined threshold over a predetermined period of time, the processor executes the water supply motion. (Fenech – [col. 13 lines 7-30] “the cleaning routine may be terminated after a predetermined length of time or 15 after a predetermined amount of fluid is dispensed , with or without regard to whether the obstruction has been decreased or removed . In some implementations , a series of two or more automated detect - clean routines is performed until either the system senses that the obstructing matter is 20 carried away or a predetermined number of cleaning routines has been completed , in which case an alternate cleaning method would be required , such as withdrawing the flexible body 214 from the surgical site for manual cleaning . The cleaning system may in some cases output a message on 25 display 111 that advises the surgeon that the automated cleaning process has not been completed or effective.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Moriyama with the teachings of Fenech to include wherein the processor acquires, from the trained model, time-series data of the confidence level corresponding to a time series of the endoscopic image, and when the confidence level is equal to or smaller than the predetermined threshold over a predetermined period of time, the processor executes the water supply motion for the benefit of having fluid “… be automatically directed towards the operational component in response to detecting a material obstruction of an image” (Fenech – abstract) “…to allow a surgeon to visualize the passageways…” (Fenech – [col. 1 line 20-45) that limits risk to the patient and is less time consuming (Fenech – [col. 1 line 20-45).
Regarding Claim 6, Moriyama in view of Fenech teach the medical system according to claim 1, wherein the processor acquires, from the trained model, time-series data of the confidence level corresponding to a time series of the endoscopic image, and performs smoothing processing on the time-series data of the confidence level, and when the confidence level after the smoothing processing is equal to or smaller than the predetermined threshold (Moriyama – col. 25 lines 28-35]). Again Moriyama only outs a determination result as seen in Figs. 4 step 9 and Fig. 12 step 38 and is silent as further teaching wherein the processor executes the water supply motion.
However Fenech, in the same field of endeavor teaches, a processor (Fenech – [col. 4 lines 25-31] “The visualization system 110 may be implemented as hardware in combination with firmware or software which interacts with or is otherwise executed by one or more computer processors, which may include the processor(s) of a control system 116.” And [col. 5 lines 8-31] and [col. 13 lines 39 – 58]) configured to control a water-supply motion and obtain a confidence level, and determine when the confidence level is equal to or smaller than a predetermined threshold the processor executes the water supply motion of washing an objective lens of the endoscope (Fenech – Fig. 9 steps 320-328, [col 12 line 19 – col. 13 line 30).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Moriyama with the teachings of Fenech to include a processor configured to control a water-supply motion and obtain a confidence level, and determine when the confidence level is equal to or smaller than a predetermined threshold the processor executes the water supply motion of washing an objective lens of the endoscope for the benefit of having fluid “… be automatically directed towards the operational component in response to detecting a material obstruction of an image” (Fenech – abstract) “…to allow a surgeon to visualize the passageways…” (Fenech – [col. 1 line 20-45) that limits risk to the patient and is less time consuming (Fenech – [col. 1 line 20-45).
Regarding Claim 7, Moriyama in view of Fenech teach the medical system according to claim 6, wherein the processor continues the autonomous control when the confidence level after the smoothing processing is larger than the predetermined threshold (Moriyama – col. 25 lines 28-35]). after completion of the water supply motion.
While Moriyama does have the processor that is configured to acquire a threshold – confidence level- that is equal to or smaller than a predetermined threshold in Fig. 4 step 8 and Fig. 8 step 19 in the determination to be low visibility, Moriyama only then outputs an alert to the user in a determination result in Fig. 4 step 9 and Fig. 12 step 38, then Moriyama teaches “after the processing in step S9, the process returns to the processing in step S2 and the processing in steps S2 to S9 is repeated.”(Moriyama – [col. 10 lines 13-15]. But Moriyama fails to specifically disclose the processor executes the water supply motion of washing an objective lens of the endoscope.
However Fenech, in the same field of endeavor teaches, a processor (Fenech – [col. 4 lines 25-31] “The visualization system 110 may be implemented as hardware in combination with firmware or software which interacts with or is otherwise executed by one or more computer processors, which may include the processor(s) of a control system 116.” And [col. 5 lines 8-31] and [col. 13 lines 39 – 58]) configured to control a water-supply motion and obtain a confidence level, and determine when the confidence level is equal to or smaller than a predetermined threshold the processor executes the water supply motion of washing an objective lens of the endoscope (Fenech – Fig. 9 steps 320-328, [col 12 line 19 – col. 13 line 30).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Moriyama with the teachings of Fenech to include a processor configured to control a water-supply motion and obtain a confidence level, and determine when the confidence level is equal to or smaller than a predetermined threshold the processor executes the water supply motion of washing an objective lens of the endoscope for the benefit of having fluid “… be automatically directed towards the operational component in response to detecting a material obstruction of an image” (Fenech – abstract) “…to allow a surgeon to visualize the passageways…” (Fenech – [col. 1 line 20-45) that limits risk to the patient and is less time consuming (Fenech – [col. 1 line 20-45).
Regarding Claim 8, Moriyama in view of Fenech teach the medical system according to claim 1, wherein the processor obtains a differential value of the confidence level, estimates, based on the differential value, a scheduled water supply timing when the confidence level becomes equal to or smaller than the predetermined threshold and the water supply motion is to be executed, and executes the water supply motion before the scheduled water supply timing. . (Fenech – [col. 13 lines 7-30] “the cleaning routine may be terminated after a predetermined length of time or 15 after a predetermined amount of fluid is dispensed , with or without regard to whether the obstruction has been decreased or removed . In some implementations , a series of two or more automated detect - clean routines is performed until either the system senses that the obstructing matter is 20 carried away or a predetermined number of cleaning routines has been completed , in which case an alternate cleaning method would be required , such as withdrawing the flexible body 214 from the surgical site for manual cleaning . The cleaning system may in some cases output a message on 25 display 111 that advises the surgeon that the automated cleaning process has not been completed or effective.”).
Regarding Claim 9, Moriyama in view of Fenech teach the medical system according to claim 8, wherein the memory stores a scene recognition trained model trained so as to detect a scene of a treatment using the treatment tool, from the endoscopic image, and the processor inputs the endoscopic image to the scene recognition trained model to allow the scene recognition trained model to detect the scene, and determines a timing to execute the water supply motion, based on the detected scene. (Fenech – [col. 13 lines 7-30] “At 326 , the method includes detecting that the obstruction of the view of the image capture instrument has been removed entirely or has been decreased to a level below the predetermined limit . At 328 , responsive to the detection of 10 the decreased obstruction , the cleaning routine is terminated by activating the control system to cease the dispensing of fluid or to cue the user to manually terminate the dispensing of fluid . In alternative embodiments , the cleaning routine may be terminated after a predetermined length of time or 15 after a predetermined amount of fluid is dispensed , with or without regard to whether the obstruction has been decreased or removed . In some implementations , a series of two or more automated detect - clean routines is performed until either the system senses that the obstructing matter is 20 carried away or a predetermined number of cleaning routines has been completed , in which case an alternate cleaning method would be required , such as withdrawing the flexible body 214 from the surgical site for manual cleaning . The cleaning system may in some cases output a message on 25 display 111 that advises the surgeon that the automated cleaning process has not been completed or effective . The surgeon may then decide to continue using the probe with the vision as - is , or the surgeon may choose to withdraw the probe for cleaning.”)
Regarding Claim 10, Moriyama in view of Fenech teach the medical system according to claim 1, wherein the processor acquires, from the trained model, a plurality of confidence levels corresponding to a plurality of positions in the endoscopic image, and when only one or more confidence levels among the plurality of confidence levels are equal to or smaller than the predetermined threshold, the processor continues the autonomous control. (Fenech – [col. 13 lines 7-30] “At 326 , the method includes detecting that the obstruction of the view of the image capture instrument has been removed entirely or has been decreased to a level below the predetermined limit . At 328 , responsive to the detection of 10 the decreased obstruction , the cleaning routine is terminated by activating the control system to cease the dispensing of fluid or to cue the user to manually terminate the dispensing of fluid . In alternative embodiments , the cleaning routine may be terminated after a predetermined length of time or 15 after a predetermined amount of fluid is dispensed , with or without regard to whether the obstruction has been decreased or removed . In some implementations , a series of two or more automated detect - clean routines is performed until either the system senses that the obstructing matter is 20 carried away or a predetermined number of cleaning routines has been completed , in which case an alternate cleaning method would be required , such as withdrawing the flexible body 214 from the surgical site for manual cleaning . The cleaning system may in some cases output a message on 25 display 111 that advises the surgeon that the automated cleaning process has not been completed or effective . The surgeon may then decide to continue using the probe with the vision as - is , or the surgeon may choose to withdraw the probe for cleaning.”)
Regarding Claim 11, Moriyama in view of Fenech teach the medical system according to claim 10, wherein the trained model is trained so as to detect a plurality of key points in the treatment tool, from the endoscopic image, and the processor acquires, from the trained model, the plurality of confidence levels corresponding to the plurality of key points. (Moriyama – [col. 5 line 42 – col. 6 line 12).
Regarding Claim 12, Moriyama in view of Fenech teach the medical system according to claim 10, wherein when only one or more confidence levels among the plurality of confidence levels are equal to or smaller than the predetermined threshold, the processor executes the water supply motion of washing the treatment tool at a position corresponding to the one or more confidence levels. (Fenech – [col. 13 lines 7-30] “At 326 , the method includes detecting that the obstruction of the view of the image capture instrument has been removed entirely or has been decreased to a level below the predetermined limit . At 328 , responsive to the detection of 10 the decreased obstruction , the cleaning routine is terminated by activating the control system to cease the dispensing of fluid or to cue the user to manually terminate the dispensing of fluid . In alternative embodiments , the cleaning routine may be terminated after a predetermined length of time or 15 after a predetermined amount of fluid is dispensed , with or without regard to whether the obstruction has been decreased or removed . In some implementations , a series of two or more automated detect - clean routines is performed until either the system senses that the obstructing matter is 20 carried away or a predetermined number of cleaning routines has been completed , in which case an alternate cleaning method would be required , such as withdrawing the flexible body 214 from the surgical site for manual cleaning . The cleaning system may in some cases output a message on 25 display 111 that advises the surgeon that the automated cleaning process has not been completed or effective . The surgeon may then decide to continue using the probe with the vision as - is , or the surgeon may choose to withdraw the probe for cleaning.”)
Claims 13 are rejected under 35 U.S.C. 103 as being unpatentable over Moriyama et al. (US8497898) hereinafter Moriyama, in view of Fenech et al. (US10039440) hereinafter Fenech in view of Gliner et al. (US11229492) hereinafter Gliner.
Regarding Claim 13, Moriyama in view of Fenech teach the medical system according to claim 1, but is silent as to further teach wherein the memory stores a scene recognition trained model trained so as to detect a scene of a treatment using the treatment tool, from the endoscopic image, and the processor inputs the endoscopic image to the scene recognition trained model to allow the scene recognition trained model to detect the scene, and performs the autonomous control, using a detection result of the scene output by the scene recognition trained model.
However Gliner, in the same field of endeavor, teaches the memory stores a scene recognition trained model trained so as to detect a scene of a treatment using the treatment tool, from the endoscopic image, and the processor inputs the endoscopic image to the scene recognition trained model to allow the scene recognition trained model to detect the scene, and performs the autonomous control, using a detection result of the scene output by the scene recognition trained model. (Gliner – [col. 7 lines 43-55] “…the controller 38 may be combined in a single physical component or, alternatively, implemented using multiple physical components. These physical components may comprise hard-wired or programmable devices, or a combination of the two. In some embodiments, at least some of the functions of the processing circuitry may be carried out by a programmable processor under the control of suitable software. This software may be downloaded to a device in electronic form, over a network, for example. Alternatively, or additionally, the software may be stored in tangible, non-transitory computer-readable storage media, such as optical, magnetic, or electronic memory.”, AND Fig. 6 Steps 200-218, [col. 11 line 11 – col. 12 line 34] “After insertion of the probe 28 along the insertion path, followed by withdrawal of the probe 28 from the live body-part, the controller 38 is configured to send (block 218) control commands to the robotic arm 40 to reinsert the probe 28 in the live body-part according to the calculated reinsertion path. The step of block 218 may be performed in response to the lens being automatically cleaned by the lens cleaning device 63 or in response to receiving a manual selection from the physician 54 via the operating controls 51.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Moriyama in view of Fenech with the teachings of Gliner to include wherein the memory stores a scene recognition trained model trained so as to detect a scene of a treatment using the treatment tool, from the endoscopic image, and the processor inputs the endoscopic image to the scene recognition trained model to allow the scene recognition trained model to detect the scene, and performs the autonomous control, using a detection result of the scene output by the scene recognition trained model for the benefit of tracking “…movement of the live body-part…” during surgery (Gliner – col. 12 lines 25-34]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure:
Alambeigi et al. (US11102381);
Aluru et al. (US2021/0127963);
Shelton IV et al. (US11369443);
Adebar et al. (US2024/0050154); and
Gowda et al. (US2025/0000337).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN E MONAHAN whose telephone number is (571)272-7330. The examiner can normally be reached Monday - Friday, 8am - 5pm.
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/MEGAN ELIZABETH MONAHAN/Examiner, Art Unit 3795
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