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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed March 24, 2026 is being considered by the examiner.
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.
Claim 11 is 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.
Claim 11 is dependent on 9 which has been canceled. For the purpose of examination, the examiner will interpret claim 11 as being dependent on claim 1.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 19 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 19 has been amended to include wherein the friction element is “configured to provide a pre-set amount of friction.” The specification fails to support this limitation. While the applicant has listed several paragraphs of the specification in the Arguments filed March 6, 2026 citing the various friction elements and their relationship among the static friction surface and the rotating friction surface, none of those citations explicitly state wherein the friction element is configured to provide a pre-set amount of friction.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 19, 21, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by
Appling et al. (US2021/0212553).
Regarding claim 19, Appling discloses an endoscope, comprising: a handle portion connected to an insertion tube assembly (Fig. 1: housing is connected to endoscope tube 14); the handle portion include an articulation control for articulating a distal end region of the insertion tube assembly (Fig. 3: steering assembly 24 is at proximal end 28 of housing 12 to control tensioning of the first and second control wires 28 and 40 to effectuate deflecting movement of the distal tip 16 [0048]); wherein the articulation control includes a lever and/or knob connected to a rotatably pulley positioned within the handle portion (Fig. 3: lever comprising connecting leg 69 and thumb grip 66 is connected to cams 68 and 70 through various handle components [0050-0051]); wherein one or more articulation wires extend around the rotatable pulley and through the distal end region of the insertion tube assembly (Fig. 3: first and second control wires 38 and 40 are wound around the outer circumference of the first and second cams 68, 70); wherein a friction element configured to provide a pre-set amount of friction is positioned between the rotatable pulley and a portion of the handle portion so as to resist rotation of the rotatable pulley relative to the housing (friction lock 94 includes compression elements 90 which may be washers 90, Fig. 3, or O-rings 92A, Fig. 5C-5E, which is capable of providing a pre-set amount of friction when the actuator dial 50 is rotated to the degree that allows for the pre-set friction); and wherein the friction element is absent a user-actuatable adjustment mechanism (friction lock 94 is passive and does not require controls or any additional specific inputs from the user [0058]).
Regarding claim 21, Appling discloses the endoscope of claim 19, wherein the friction element
comprises rubber (Fig. 7A-8C: friction lock 94C comprises an elastomer gasket 108 [0060]).
Regarding claim 22, Appling discloses the endoscope of claim 19, further disclosing wherein the
friction element comprises an o-ring (Fig. 3-5E: friction lock 94 includes compression element 90, which
may comprise o-rings 92A [0057]).
Regarding claim 24, Appling discloses the endoscope of claim 19, further disclosing wherein the
portion of the handle portion extends through the rotatable pulley (Fig. 3: portion of the first shell 32 of
housing 12, particularly axle 42 extends through cams 68 and 70 [0051]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-11, 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Shtul et al.
(US2021/0244267) in view of Kawanishi (US2023/0018783) and Tobien (US2018/0361034).
Regarding claim 1, Shutl discloses the endoscope, comprising: an insertion tube assembly (insertion tube 118) and umbilical connected to an elongate handle portion (umbilical cable 136); the elongate handle portion having an upper end region (Fig. 1: endoscope handle 1-2 including body comprising opening for working channel 134) and a lower end region (interface 116); wherein the upper end region of the elongate handle portion includes at least one of: an irrigation, aspiration, and/or insufflation control (suction control valve 138 and air/water control valve 140 [0086]), and a tool port opening (Fig. 1: port opening for working channel 134); wherein the insertion tube assembly and umbilical extend from the lower end region (Fig. 1: insertion tube 118 and umbilical cable 136 extend from interface 116). Although Shtul discloses navigation cables in the insertion tube for driving the bendable portion of the insertion tube (Fig. 9; [0148]), Shtul fails to disclose the details of a drive mechanism for pulling the navigation wires, and thus fails to disclose an articulation control for articulating the bending portion. In the same field of endeavor, Kawanishi teaches a substantially similar endoscope comprising: an insertion tube assembly and umbilical connected to an elongate handle portion (Fig. 1: flexible tube portion 6 and universal cord 8 [0022]), wherein an upper end region of the elongate handle portion includes an articulating control for articulating a distal portion of an insertion tube assembly connected to the handle portion (Fig. 4: proximal end of operating portion 3 comprises bending operation lever 15 to bend the bending portion 5 of the insertion portion 2 up and down [0024]). Although Shtul appears to show articulating control knobs in the drawing of Fig. 1, since Shtul fails to explicitly disclose the purpose of the control knobs illustrated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted any known articulating control mechanism, including that of Kawanishi, for the articulating control mechanism of Shtul, as the articulating control mechanism of Kawanishi is well-known in the endoscope art for pulling navigation/pull wire for articulating a flexible bending section of an endoscopic insertion tube.
Shtul and Kawanishi fail to disclose wherein the irrigation, aspiration, and/or insufflation control comprises a fluid flow adjustment mechanism, wherein the fluid flow adjustment mechanism is configured to retain a fluid control button in an at least partially depressed state to provide a constant minimum fluid flow rate, and wherein the fluid control button is further depressible from the at least partially depressed state to provide a higher fluid flow rate than the constant minimum fluid flow rate.
In the same field of endeavor, In the same field of endeavor, Tobien teaches a medical push button valve intended to be equipped on medical instruments such as an endoscope (endoscopes are equipped with a valve in which flow can be switched on or off [0004]), similar to that of Shtul, the medical push button valve configured to control fluid flow (medical push button valve 1 [0044]), including aspiration (suction [0046]), further wherein the medical push button valve comprises a fluid flow adjustment mechanism configured to retain the button in an at least partially depressed state to provide a constant minimum fluid flow rate, and wherein the fluid control button is further depressible from the at least partially depressed state to provide a higher fluid flow rate than the constant minimum fluid flow rate (pressure element 9 of valve piston 4 of the valve 1 can be locked in each intermediate position between the position closing the flow channel and the position releasing the flow channel [0072], suggestive that there are more lockable position other than fully closed and fully released, and the valve may be locked in a halfway position that would partially be released). Since Shtul fails to disclose the details to the air/water control valve or the suction valve, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any known valve configuration known in the art, including the valve taught by Tobien, as the valve system for Shtul.
Regarding claim 2, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 1. Shtul discloses wherein the upper end region of the elongate handle portion includes the irrigation, aspiration, and/or insufflation control (suction control valve 138 and air/water control valve 140 [0086] in a proximal region of the endoscope handle 102). Shtul, modified by Kawanishi, teaches wherein the upper end region of the elongated handle includes at least the articulation control (Kawanishi Fig.4: proximal end of operating portion 3 comprises bending operation lever 15 to bend the bending portion 5 of the insertion portion 2 up and down [0024]).
Regarding claim 3, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 1. Shtul further discloses wherein the upper end region of the elongate handle portion includes at least the tool port opening (Fig. 1: port opening for working channel 134). Shtul, modified by Kawanishi, further teaches wherein the upper end region of the elongate handle portion includes at least the articulation control (Kawanishi Fig.4: proximal end of operating portion 3 comprises bending operation lever 15 to bend the bending portion 5 of the insertion portion 2 up and down [0024]).
Regarding claim 4, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 1. Shtul further discloses wherein the upper end region of the elongate handle portion includes at least the irrigation, aspiration, and/or insufflation control and the tool port opening (Fig. 1: suction control valve 138 and air/water control valve 140 [0086] and port opening for working channel 134 in the upper proximal region of the handle).
Regarding claim 5, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 1. Shtul further discloses wherein the upper end region of the elongate handle portion includes the irrigation, aspiration, and/or insufflation control, and the tool port opening (Fig. 1: suction control valve 138 and air/water control valve 140 [0086] and port opening for working channel 134 in the upper proximal region of the handle). Shtul, modified by Kawanishi, further teaches wherein the upper end region of the elongate handle portion includes the articulation control (Kawanishi Fig.4: proximal end of operating portion 3 comprises bending operation lever 15 to bend the bending portion 5 of the insertion portion 2 up and down [0024]).
Regarding claim 6, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 1. Shtul further discloses wherein the irrigation, aspiration, and/or insufflation control is an irrigation control (air/water control valve 140 [0086]).
Regarding claim 7, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 1. Shtul further discloses wherein the irrigation, aspiration, and/or insufflation control is an aspiration control (suction control valve 138 [0086]).
Regarding claim 8, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 1. Shtul further discloses wherein the irrigation, aspiration, and/or insufflation control is an insufflation control (air/water control valve 140 [0086]).
Regarding claim 11, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 1, wherein the fluid flow adjustment mechanism comprises a rotatable knob (Fig. 5a shows the valve fully closed, Fig. 6a-8c shows the valve fully open, but in an unlocked, partially locked and fully locked configuration [0032-0043]; rotation of pressure element 9 disengages the groove 28 from the latching surface 27, and when the surgeon releases downward pressure, spring element 13 pushes the pressure element 9 and valve piston 4 in the closed position [0090])
Regarding claim 13, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 1, wherein the irrigation, aspiration, and/or insufflation control comprises a normally closed valve positioned within the elongate handle portion (spring element 13 in the valve 1 biases the valve piston 4 in the closed, raised position [0048]).
Regarding claim 14, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 1. Shtul further discloses wherein the irrigation, aspiration, and/or insufflation control controls fluid flow along a first fluid flow path extending through a first lumen (Fig. 2A: control valve 138 is between the vacuum source 112 and working channel 134 [0088]; evacuation tube 152, running through the umbilical, joins to working channel 134 through a Y-tube connection to make up the first fluid flow path; both control valve 138 and control valve 146 may control fluid [0088]); wherein the first lumen extends through the umbilical (evacuation tube 152 extends through the lumen and is part of the first fluid flow path); wherein the first fluid path is in fluid communication with a first tool lumen extending through the insertion tube assembly and in communication with the tool port opening (first fluid path comprises working channel 134, as the working channel 134 and evacuation tube 152 may be connected by Y- connector or comprise a single channel [0088]).
Regarding claim 15, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 14. Shtul further discloses the endoscope comprising a valve located between the tool port opening and the first fluid path (Fig. 2A: valve 138).
Regarding claim 16, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 14. Shtul further discloses wherein a second fluid path extends through a second lumen of the umbilical; and wherein the second fluid path is in fluid communication with the first tool lumen (Fig. 2B: fluid supply tube 154 is a second fluid path extending through a second lumen of the umbilical 136 [0105], irrigation tubes 154 can be merged at a four-way connector to connect to working channel 134 and other channels/conduits [0106]).
Regarding claim 17, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 1. Shtul, modified by Kawanishi, further teaches wherein the articulation control for articulating a distal portion of an insertion tube assembly connected to the handle portion is a lever (Kawanishi Fig.4: proximal end of operating portion 3 comprises bending operation lever 15 to bend the bending portion 5 of the insertion portion 2 up and down [0024]).
Regarding claim 18, Shtul, modified by Kawanishi and Tobien, discloses the endoscope of claim 17. Shtul, modified by Kawanishi, further teaches wherein the lever articulates in a plane that is coextensive with a longitudinal axis of the elongate handle portion (Kawanishi Fig. 6 & 7: operation lever 15 is pushed with a thumb in the right-down direction, the down direction is on a plane coextensive with the longitudinal axis of the elongate handle portion).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Shtul, modified by Kawanishi, Tobien and Abouzgheib (US2018/0344142).
Regarding claim 12, Shtul, modified by Kawanishi and Tobien discloses the endoscope of claim 1, but fails to teach wherein the irrigation, aspiration, and/or insufflation control is specifically a pinch valve positioned within the elongate handle portion configured to compress a flexible fluid tube. In the same field of endeavor, Abouzgheib teaches an endoscopic irrigation, aspiration and/or insufflation control comprised of a pinch valve for controlling the flow of fluid by compressing a flexible fluid tube (conduits 210 and 220 may be compressed into occlusion by pinching the conduits so that the fluid cannot flow through [0071-0072]), which can alternatively be substituted for any other valve including ball valves, butterfly valves and the like ([0121]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted any valve structure known in the endoscope art, including the pinch valve taught by Abouzgheib, as the valve of Shtul, since the various valve structures are alternatively interchangeable and can function similarly – to control fluid flow in an endoscope system.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Appling in view of
Ataollahi et al. (US2014/0350462).
Regarding claim 20, Appling discloses the endoscope of claim 19, and wherein the friction element is configured to permit articulation of the distal end region of the insertion tube assembly when the articulation control is subjected to a force; and wherein the friction element is configured to retain the distal end region of the insertion tube assembly in an articulated configuration after removal of the force from the articulation control (friction lock 94-94D prevents tension of wires 38 and 40 from
providing undesired rotation of the cams 68 and 70 and actuator dial 50 back to the neutral position
upon release of the actuator dial 50 by the user during operation of the control handle, friction lock
allows user to release their thumb from the thumb grip and still maintain a specific deflection of the
distal tip [0056]). Appling fails to disclose the amount of force required to permit articulation of the
distal end region, therefore fails to disclose articulation of the distal end region of the insertion tube
assembly when the articulation control is subjected to a force of 1 Newton or more. In the same field of
endeavor, Ataollahi teaches an endoscope, comprising a distal end region articulated by pull wires,
wherein the pull wires can be articulated by a knob mechanism, wherein the pull wires can apply a maximum force of 21.5 Newtons (Fig. 3, [0043]). Since Appling fails to disclose the amount of force
required to articulate a distal end region of an endoscope, it would have been obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention to have used any known
force amount known in the art, including the one taught by Ataollahi. Additionally, it would have been
obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that control levers for pulling pull wires in the endoscope art typically can be actuated using
forces greater than 1 Newton.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Appling in view of Cook
(US2022/0161003).
Regarding claim 23, Appling discloses the endoscope of claim 19, but fails to disclose wherein
the friction element comprises friction grease. In the same field of endeavor, Cook teaches a friction
element between a connector and a cannula, wherein the friction element can comprise an o-ring or
friction grease (o-ring 242 or any other suitable resistance mechanism is contemplated, including friction grease [0133]). In view of Cook, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included friction grease as an additional or alternative friction element to the friction element of Appling.
Response to Arguments
Applicant's arguments filed March 6, 2026 have been fully considered but they are not persuasive.
Regarding claim 19, applicant has amended the claim to specify the friction element as being “configured to provide a pre-set amount of friction”. Since there is no measurement of friction specified to be the pre-set amount of friction, the examiner has interpreted that the pre-set amount of friction to hold Appling’s actuator dial 50 in a pre-set amount of rotation is the pre-set amount of friction to meet the claim. For example, if the friction element is configured to provide a 1 newton of friction to hold the actuator dial 50 in 15 degrees of rotation, the pre-set amount of friction is 1 newton. Further, the specification does not contain support for this limitation.
It appears that the applicant is intending to state that the friction force between the friction element and the rotating friction surface of the pulley remain the same regardless of the amount of rotation of the of the lever/knob. The friction force felt between the friction element and the rotating friction surface of the pulley varies based on whether the two object are stationary or moving relative to one another, resulting the kinetic friction when the lever/knob is being rotated, and static friction when the lever/knob is rotated from the normal position and stationery in the rotated position. This information seems to be pertinent when considering future amendments.
Applicant has also included wherein the friction element is absent a user-actuatable adjustment mechanism and argues that Appling does not teach this limitation. The examiner respectfully disagrees. Similar to applicant’s friction element, Appling’s friction lock appears to automatically hold the actuator dial 50 in the rotated position, even when no load is being applied to the actuator dial 50 by the user. There does not appear to be a lock lever or brake lever that needs to be applied for the friction lock to perform in the Appling reference. Further, the end of paragraph [0058] of Appling states that the friction lock 94, 94A is passive and does not require controls of additional specific inputs from the user.
For the reasons stated above, the arguments regarding claim 19 were not persuasive.
Regarding claim 1, applicant has amended to include wherein the fluid flow adjustment mechanism is configured to retain a fluid control button in an at least partially depressed state to provide a constant minimum fluid flow rate, and wherein the fluid control button is further depressible from the at least partially depressed state to provide a higher fluid flow rate than the constant minimum fluid flow rate, and argues that Tobien fails to teach such limitation. The examiner respectfully disagrees. Tobien teaches wherein the pressure element 9 of the valve piston 4 can be locked in each intermediate position between the position closing the flow channel 3 and the position releasing the flow channel 3 [0072]. This suggests that the pressure element 9/valve piston 4 can be held at a halfway position, which would provide a lower flow rate, as the opening of sealing body 15 and valve seat 17 would be smaller. The examiner anticipates that the applicant may argue that the adjustment of fluid flow rate is dependent on the rotation of the pressure element 9, and not axial movement of the pressure element 9/valve piston 4, however, it appears that the locking component is controlled by the rotation of pressure element 9 and fluid flow rate is controlled by axial movement of pressure element 9/valve piston 4, which controls the seal between sealing body 15 and valve seat 17. This appears also to be supported by the Figs. 5a-8c and their description [0033-0043], which shows that the locking mechanism may be unlocked (Fig. 6a-c), partially locked (Fig. 7a-c), and fully locked (Fig. 8a-c), through rotation pressure element 9, and the valves in all three locking configurations are in the release/open position. For the reasons stated above, the arguments regarding claim 1 were not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LI-TING SONG/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
06/06/26
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