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 and Species F in Figs. 49-51, in reply filed 01/07/2025 is acknowledged.
Response to Amendment
The amendment filed 03/27/2026 has been entered. Claims 1-14 and 19-24 are pending. Claims 10-14 and 22-24 are withdrawn because they are drawn to a non-elected species. Claims 15-18 are cancelled. Claims 1 and 4-6 are amended. Claims 1-9 and 19-21 are examined below.
Response to Arguments
Applicant’s arguments, see pages 7-13, filed 03/27/2026, with respect to the rejections identified in the non-final office action dated 02/20/2026, have been fully considered. Applicant has amended the independent claim with newly added limitations. Such newly added amendments to the independent claim changes the scope of the claims. Therefore, the rejections previously identified in the non-final office action dated 02/20/2026, have been withdrawn. However, upon further consideration, a new ground of rejection is made below und 35 U.S.C. §103. Please see section 35 U.S.C. §103 for further explanation.
Claim Objections
Claim 6 objected to because of the following informalities:
Claim 6 recites the limitation, “wherein the processor generates, as the usage status information on the specific mode, a number of times the specific mode has been used, or a usage time of the specific mode.” Such language is cumbersome and confusing. It is suggested to amend the limitation to state, “wherein the processor is further configured to generate
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 1-2, 4-6, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Amir Belson (US2007/0135803) hereinafter Belson, in view Buda et al. (US2018/0225420) hereinafter Buda, in view of Roelle et al. (US2011/0319815) herein after Roelle.
Regarding Claim 1, Belson discloses an endoscope system ([0007] “In keeping with the foregoing discussion, the present invention takes the form of methods and apparatus for performing endoscopic colectomy that combine the advantages of the laparoscopic and endolumenal approaches.”) comprising:
an endoscope (Fig. 25 endoscope 20) comprising a bending portion (Fig. 25 controllable portion 28), the bending portion (Fig. 25 controllable portion 28) comprises multiple joints (Fig. 25 multiple segments 30 having hinged joints 506 and 508 as shown in Figs. 29B/29C, ([0239] “The automatically controlled portion 28 is segmented, and each segment is capable of bending through a full range of steerable motion. The distal portion 24 is also a controllable segment.” And [0264]);
an actuator ([0242] “The controllable portion 28 is composed of at least one segment 30, and preferably several segments 30, which are controllable via a computer and/or electronic controller (controller) 45 located at a distance from the endoscope 20. Each of the segments 30 has tendons mechanically connected to actuators to allow for the controlled motion of the segments 30 in space. The actuators driving the tendons may include a variety of different types of mechanisms capable of applying a force to a tendon, e.g., electromechanical motors, pneumatic and hydraulic cylinders, pneumatic and hydraulic motors, solenoids, shape memory alloy wires, electronic rotary actuators or other devices or methods as known in the art. If shape memory alloy wires are used, they are preferably configured into several wire bundles attached at a proximal end of each of the tendons within the controller. Segment articulation may be accomplished by applying energy, e.g., electrical current, heat, etc., to each of the bundles to actuate a linear motion in the wire bundles which in turn actuate the tendon movement. The linear translation of the actuators within the controller may be configured to move over a relatively short distance, e.g., within a few inches or less such as +/−0.1 inch, to accomplish effective articulation depending upon the desired degree of segment movement and articulation.”) that outputs a driving force for bending the bending portion (Fig. 25 controllable portion 28), the actuator ([0242]) configured to drive the multiple joints independently ([0242], [0247], And [0264]); and
a processor (Fig. 25 motion controller 25, [0246] “The motion controller 45 controls the movement of the segmented automatically controlled proximal portion 28 of the body 21. This controller 45 may be implemented using a motion control program running on a microcomputer or using an application-specific motion controller. Alternatively, the controller 45 may be implemented using, e.g., a neural network controller.”) comprising hardware ([0246 -0247] “The actuators applying force to the tendons may be included in the motion controller unit 45, as shown, or may be located separately and connected by a control cable.”), wherein the processor (Fig. 25 motion controller 25, [0246]) is configured to:
control the actuator ([0247] “The actuators applying force to the tendons may be included in the motion controller unit 45, as shown, or may be located separately and connected by a control cable.”) by switching one or more modes of controlling ([0348] push-pull mode, [0297, 0467] manual mode / automatic mode, [0441] fail-safe mode) the multiple joints (Fig. 25 multiple segments 30 having hinged joints 506 and 508 as shown in Figs. 29B/29C), wherein each one of the one or more mode ([0348] push-pull mode, [0297, 0467] manual mode / automatic mode, [0441] fail-safe mode) indicates at least one joint among the multiple joints to be controlled during usage of the endoscope (Fig. 25 endoscope 20),
generate usage status information ([0578] “Position data such as location and/or orientation data from the tracking subsystem 20 is in turn relayed to the data processor 16. The data processor 16 is adapted to receive position/orientation data from the tracking subsystem 20 and operable to render a volumetric perspective image and/or a surface rendered image of the region of interest. The volumetric perspective and/or surface image is rendered 36 from the scan data 32 using rendering techniques well known in the art. The image data may be further manipulated 38 based on the position/orientation data for the surgical instrument 12 received from tracking subsystem 20. Specifically, the volumetric perspective or surface rendered image is rendered from a point of view which relates to position of the surgical instrument 12.”)
Belson is silent at explicitly teaching whether the processor is additionally configured to generate a first identifier that comprises information for identifying a case in which the endoscope is used and output the first identifier associated with the usage status information and generate usage status information on a specific mode among the one or more modes used in a case, wherein the usage status information on the specific mode indicates whether the specific mode is used in the case or not, and output the first identifier associated with the usage status information.
However Buda, in the same field of endeavor, teaches a processor configured to generate a first identifier that comprises information for identifying a case in which the endoscope is used, and output the first identifier associated with the usage status information. (Buda -[0037] “Procedural departments 132 and assets may include, but are not limited to, procedural specialists, surgical cameras, angiographic imaging devices, hemodynamic monitors, and endoscopes.” [0039] “The server 102 may be configured to add data from each domain 114, 120, 122, 124, 130, 136 to the patient EMR 144 and allow direct access to the patient EMR 144 by appropriate assets within each domain 114, 120, 122, 124, 130, 136. Furthermore, the server 102 may include a collaborator resource monitor 146 to monitor which assets, domains 114, 120, 122, 124, 130, 136, or other resources are being accessed by a healthcare provider at any given time, including tagging particular resource allocations with an identifier corresponding to a collaborating healthcare provider such that any collaborations added to the patient EMR 144 or electronic medical record are associated with the healthcare provider.”
[0043] “ Data from client device 150, 152, 154, 156, 158, 160, or the client devices 150, 152, 154, 156, 158, 160 themselves, may be tagged with patient 116, 118 identifiers or other metrics. Similar tags may also be added to EMRs 144 to facilitate searching.”).
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 Belson to include the teachings of Buda to have configured to generate a first identifier, which is information for identifying a case in which the endoscope is used and output the first identifier associated with the usage status information for the benefit of “…coordinating and facilitating communication and data sharing between healthcare providers and patients includes a computer system that establishes data communication with separate healthcare systems and monitoring instruments” (Buda – abstract).
Belson in view of Buda fail to explicitly teach the processor is further configured to generate usage status information on a specific mode among the one or more modes used in a case, wherein the usage status information on the specific mode indicates whether the specific mode is used in the case or not and output the first identifier associated with the usage status information.
However Roelle, in the same field of endeavor teaches the processor is further configured to generate usage status information on a specific mode among the one or more modes used in a case, wherein the usage status information on the specific mode indicates whether the specific mode is used in the case or not (Roelle – [0183-0186] master following mode: idle mode, default mode, auto home mode, set-up mode; [0312-0314] actual fracture mode.) and output the first identifier associated with the usage status information (Roelle – [0313] “…the system could display a visual indicator of device failure.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Belson in view of Buda with the teachings of Roelle to include the processor is further configured to generate usage status information on a specific mode among the one or more modes used in a case, wherein the usage status information on the specific mode indicates whether the specific mode is used in the case or not and output the first identifier associated with the usage status information for the benefit of “communicating the point of failure and type if possible…” in order for the user to determine whether it is necessary to stop “…operation of the device…” or “…permit a user with the option of continuing in a reduced workspace or reduced functionality… [to] aid an operator in safely performing their tasks or exiting the workspace” (Roelle – [0314])
Regarding claim 2, Belson in view of Buda in view of Roelle teaches the endoscope system according to claim 1, further discloses wherein the endoscope system communicates with a first server (Buda - [0037-0041] remote servers), the first server (Buda - [0037-0041] remote servers) acquires the first identifier and the usage status information, and the first server outputs a billing amount based on the usage status (Buda -[0038] “A systems domain 136 allows server 102 access to administrative systems 138, 140, 142 within the hospital 100 such as a scheduling system 138, a billing system 140, and a hospital record system 142. Each system 138, 140, 142 may include plugins to facilitate data communication with the server 102.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Belson in view of Bude in view of Roelle with the teachings of Buda to include wherein the endoscope system can communicate with a first server to acquire the first identifier and the usage status information, and outputs a billing amount for use of the mode based on the usage status information for the benefit of “…coordinating and facilitating collaborative communication, education, and data access between healthcare providers and patients” [0006].
Regarding Claim 4, Belson in view of Buda in view of Roelle teaches the endoscope system according to claim 2, wherein the endoscope system includes a controller (Belson - Fig. 25 steering controller 45, [0242] “The controllable portion 28 is composed of at least one segment 30, and preferably several segments 30, which are controllable via a computer and/or electronic controller (controller) 45 located at a distance from the endoscope 20.”) configured to input (Belson – [0297] “The control signals from the steering control to the selectively steerable distal portion 25 are monitored by an electronic motion controller. Once the correct curve of the selectively steerable distal portion 25 for advancing the distal end of the instrument 22 into the sigmoid colon has been selected, the curve is logged into the memory of the electronic motion controller as a reference. Whether operated in manual mode or automatic mode, once the desired curve (24) has been selected with the selectively steerable distal portion 25, as the articulating instrument 22 advances distally, the selected curve 24 is propagated proximally along the automatically controlled proximal portion 26 using an electronic motion controller.”) the one or more modes (Belson - ([0348] push-pull mode, [0297, 0467] manual mode / automatic mode, [0441] fail-safe mode) and
Belson in view of Buda is silent at explicitly teaching whether the processor is configured to use information on usage status of the one or more modes inputted via the controller to generate the usage status information on the specific mode.
However Roelle, in the same field of endeavor, teaches a controller (Roelle – [0021] “…a controller including a master input device, where the controller generates a position control signal in response to the master input device to position the working section at a desired position; one or more actuators operatively coupleable to the one or more positioning elements, where the actuators manipulate the positioning elements based on the position control signal to drive at least a first portion of the shapeable instrument to position the working section toward the desired position…”) configured to input the one or more modes (Roelle – [0183-0186] master following mode: idle mode, default mode, auto home mode, set-up mode; [0312-0314] actual fracture mode) and a processor is configured to use information on usage status of the one or more modes (Roelle – [0183-0186] master following mode: idle mode, default mode, auto home mode, set-up mode; [0312-0314] actual fracture mode.) inputted via the controller to generate the usage status information (Roelle – [0033] “…the controller can trigger an operator alert signal alarm to the master input device. The operator signal can cause a haptic effect on the master input device for feedback. In some variations, the controller triggers the operator alert signal only if the signal is greater than a pre-determined level. Any number of safety measures can be employed when the controller triggers the operator alert signal. For example, the controller can be configured to stop movement of the shapeable instrument; the controller can be configured to reverse movement of the shapeable instrument; and/or the controller can be configured to increase a force required to operate the master input device.”). on the specific mode (Roelle – [0183-0186] master following mode: idle mode, default mode, auto home mode, set-up mode; [0312-0314] actual fracture mode.)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Belson in view of Buda with the teachings of Roelle to include the processor is configured to use information on usage status of the one or more modes inputted via the controller to generate the usage status information on the specific mode for the benefit of providing feedback to the user (Roelle – [0033])
Regarding claim 5, Belson in view of Buda in view of Roelle teach the endoscope system according to claim 1, wherein the processor detects whether the specific mode (Roelle – [0312-0314] actual fracture mode.) is used in the case or not (Roelle – [0033], based on information on usage status of the one or more modes (Roelle – [0312-0314] actual fracture mode.) in the case, and generate the usage status information on the specific mode when the specific mode (Roelle – [0312-0314] actual fracture mode.) is used in the case (Roelle – [0033] “…the controller can trigger an operator alert signal alarm to the master input device. The operator signal can cause a haptic effect on the master input device for feedback. In some variations, the controller triggers the operator alert signal only if the signal is greater than a pre-determined level. Any number of safety measures can be employed when the controller triggers the operator alert signal. For example, the controller can be configured to stop movement of the shapeable instrument; the controller can be configured to reverse movement of the shapeable instrument; and/or the controller can be configured to increase a force required to operate the master input device.”). on the specific mode (Roelle – [0312-0314] actual fracture mode.).
Regarding claim 6, Belson in view of Buda in view of Roelle teach the endoscope system according to claim 5, wherein the processor generates, as the usage status information on the specific mode (Roelle – [0312-0314] actual fracture mode.) , a number of times the specific mode has been used, or a usage time of the specific mode (Roelle -[0317-0323] “ One aspect of using any flexing material is that the bulk properties of flexible sections change over time as the section is repeatedly flexed. Materials may fatigue, slightly surpass their elastic regions or in the case of composites experience slip on the micro-scale between materials. In extreme cases, these behaviors qualify as a fracture of the material…If the degradation is fairly continuous and smoothly progressing in time, knowledge of the level of degradation could be useful to the system operator. This “state of the health” of the flexible section as well as other adapted properties are useful information for users and extra-control subsystems. The state of health could be conveyed to the user as numerical percentage of original life or with an icon such as a battery level type indicator.
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Belson in view of Buda in view of Roelle with the additional teachings of Roelle wherein the processor generates, as the usage status information on the specific mode, a number of times the specific mode has been used, or a usage time of the specific mode for the benefit of providing “a state of health” to the user (Roelle -[0317-0323]).
Regarding Claim 19, Belson in view of Buda in view of Roelle teach the endoscope system according to claim 1, wherein the one or more modes (Belson -manual or automatic mode) comprise at least one of the following: a first mode to control only a distal end side joint of the multiple joints (Belson – [0246] “The steering controller 47 allows the user to selectively steer or bend the selectively steerable distal portion 24 of the body 21 in the desired direction 26.”) a second mode to control only a proximal end side joint of the multiple joints, (Belson – [0242] “Each of the segments 30 has tendons mechanically connected to actuators to allow for the controlled motion of the segments 30 in space. [0247] “The tendons controlling the steerable distal portion 24 and the controllable segments 30 extend down the length of the endoscope body 21 and connect to the actuators. FIG. 25 shows a variation in which the tendons pass through the handle 32 and connect directly to the motion controller 45 via a quick-release connector 60. In this variation, the tendons are part of the control cable 46, although they could independently connect to the actuators, so long as the actuators are in communication with the controller 45.”), and a third mode to control the multiple joints independently (Belson - [0313-0314] “….a continuous band of electro-polymeric material that is formed in an annular ring and placed around the periphery of a segment may be made to be longer in length so that it extends over several, i.e., over at least two, hinges or universal joints, as shown in FIG. 39A. It may be made in a single continuous piece and may be made to cover a portion of the length or even the entire length of the flexible endoscope structure. In this configuration 90, independently controllable regions of the electro-polymeric material, e.g., regions 96, 98, 100, 102 and so on, may be created and located so that they are able to exert bending forces on each hinge, joint, or universal joint along the length of the endoscope, or as many hinges, joints or universal joints as are contained within the sleeve of electro- polymeric materials 92, 94. …a plurality of individually controllable regions (FIG. 39A). In this embodiment, the articulating instrument 90 includes 6 hinged segments covered by activated polymer material 92, 94.”).
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 Belson in view of Buda in view of Roelle with the additional teaching of Belson to include wherein the third mode to control the multiple joints independently for the benefit of providing “…a disposable cover over a segmented structure comprising hinges and activated polymer materials coupled to the hinges…[so that]… the sheath is cleanable, washable, and/or reusable” all while allowing “…for bending in any direction relative to the segment longitudinal axis…” (Belson -310]).
Regarding Claim 20, Belson in view of Buda in view of Roelle teach the endoscope system according to claim 19, wherein the third mode (Belson - [0313-0314] “a plurality of individually controllable regions (FIG. 39A). In this embodiment, the articulating instrument 90 includes 6 hinged segments covered by activated polymer material 92, 94.”). comprises at least one of the following a fourth mode to control the multiple joints as a one long joint (Belson – [0313] “…segment may be made to be longer in length so that it extends over several, i.e., over at least two, hinges or universal joints, as shown in FIG. 39A. It may be made in a single continuous piece and may be made to cover a portion of the length or even the entire length of the flexible endoscope structure.”), and a fifth mode to control each of the multiple joints (Belson - [0313-0314] “a plurality of individually controllable regions (FIG. 39A). In this embodiment, the articulating instrument 90 includes 6 hinged segments covered by activated polymer material 92, 94.”).
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 Belson in view of Buda in view of Roelle with the additional teaching of Belson to include wherein the third mode comprises at least one of a fourth mode, as described above, or a fifth mode, as described above, for the benefit of providing a bending portion that is independently control regions (Belson – [0313]).
Regarding Claim 21, Belson in view of Buda in view of Roelle teach the endoscope system according to claim 1, wherein the specific mode comprises at least one of the following:
wherein the one or more modes (Belson -manual or automatic mode) comprise at least one of the following: a first mode to control only a distal end side joint of the multiple joints (Belson – [0246] “The steering controller 47 allows the user to selectively steer or bend the selectively steerable distal portion 24 of the body 21 in the desired direction 26.”) a second mode to control only a proximal end side joint of the multiple joints, (Belson – [0242] “Each of the segments 30 has tendons mechanically connected to actuators to allow for the controlled motion of the segments 30 in space. [0247] “The tendons controlling the steerable distal portion 24 and the controllable segments 30 extend down the length of the endoscope body 21 and connect to the actuators. FIG. 25 shows a variation in which the tendons pass through the handle 32 and connect directly to the motion controller 45 via a quick-release connector 60. In this variation, the tendons are part of the control cable 46, although they could independently connect to the actuators, so long as the actuators are in communication with the controller 45.”), and a fifth mode to control the multiple joints independently.
Allowable Subject Matter
Claims 3 and 7-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MEGAN ELIZABETH MONAHAN/Examiner, Art Unit 3795
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