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 .
This Office Action is in response to the amendments dated August 24, 2026.
Claims 1 and 16-30 are pending.
Drawings
In light of the Response dated August 24, 2026, the Drawings dated July 26, 2024, are acceptable.
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, 16-22, and 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Lwin et al. (US 2020/0315720).
Regarding Claim 1, Lwin discloses:
An endoscope comprising:
an insertion unit that is bendable in a first direction and a second direction intersecting the first direction (see Figs. 4A and 5A showing the insertion section of the scope with knobs 6; see Paragraph 0080 discussing the Left/Right and Up/Down angulation of the device);
a first illumination window that is provided on a distal end surface of the insertion unit (see Fig. 7A showing “Light” as the illumination windows, the first window being on the left side);
an observation window that is provided on the distal end surface and is used to observe an inside of an object to be examined illuminated with illumination light (see Fig. 7A showing the observation window “Objective Lens”);
a first treatment tool outlet port (see Fig. 7A showing the Grasper opening) which is provided on the distal end surface and out of which a first treatment tool is capable of being led (opening for a grasper); and
a second treatment tool outlet port (see Fig. 7A showing the Aux opening) which is provided on the distal end surface and out of which a second treatment tool is capable of being led (opening can be used for hemostatic forceps and/or clip; see Paragraph 0167),
wherein
in the first direction (left to right in Figs. 7A/7B, see below), a center of the first illumination window (Light 1), a center of the observation window (Objective Lens 2), a center of the second treatment tool outlet port (Aux 3), and a center of the first treatment tool outlet port (Grasper 4) are arranged in this order (Figs. 7A/7B shows this order, see below),
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and
in the second direction (down to up in Fig. 7A, see below), a center of the second treatment tool outlet port (Aux 3), a center of the observation window (Objective Lens 2), and a center of the first treatment tool outlet port (Grasper 4) are arranged in this order (this order is shown in Fig. 7A, see below).
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Lwin does not explicitly disclose a distance between the center of the observation window and the center of the second treatment tool outlet port is longer than a distance between the center of the observation window and the center of the first treatment tool outlet port. However, the Drawings clearly show this configuration with the distance between the observation window and the auxiliary channel being greater than the distance between the observation window and the grasper port (see below where 1 is longer than 2).
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Therefore, it would have been at least obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have Lwin’s disclosed configuration with the distance between the window and the auxiliary channel being greater than the distance between the window and the grasper channel. Such a configuration is shown in the reference and provides the desired positioning of the components as set forth in Paragraphs 0162-0170).
Regarding Claim 16, Lwin does not explicitly disclose wherein a diameter of the second treatment tool outlet port is larger than a diameter of the first treatment tool outlet port. However, making small changes to dimensions or relative proportions is considered obvious (see MPEP 2144.04.IV.A (citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). Furthermore, Lwin teaches changing the sizes of inner channel diameters based on instrument sizes (see Paragraph 0163). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Lwin’s channel sizes. Such a modification does not change the function of the device as tools come in a variety of shapes and sizes. Changing the size of one lumen to allow for a larger or smaller tool to be inserted tailors the device to its particular use.
Regarding Claim 17, Lwin does not explicitly disclose wherein the first direction is along an up/down direction of an image based on electrical signals from an image sensor that receives light incident through the observation window. However, rotating the device 90 degrees gives this configuration (see below). The Grasper opening and the Aux opening would be in the proper location relative to the light and observation windows.
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Regarding Claim 18, Lwin as modified further discloses wherein the second direction is along a left/right direction of the image (see rejection of claim 17, with the reorientation, the Aux opening 3, Objective Lens 2, and Grasper 4 are in order as claimed).
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Regarding Claim 19, Lwin does not explicitly disclose wherein in the second direction, the center of the first illumination window, the center of the observation window, and the center of the first treatment tool outlet port are arranged in this order. The drawings, see Figs. 7A/7B, do not show the center of the first illumination window. However, However, making small changes to dimensions and slightly rearranging parts are considered obvious when the function of the device does not change (see MPEP 2144.04.IV.A (citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) and 2144.04.VI.C (citing In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Lwin’s configuration to have the center of the observation window slightly higher than that of the illumination window without going beyond the center of the grasper outlet. This can be achieved by having a small illumination window that is slightly lower, moving the observation window slightly higher, or by other means without changing the function of the device. A person having ordinary skill in the art would have a reasonable expectation of success as such minor adjustments do not fundamentally change the function of the device.
Regarding Claim 20, Lwin further discloses wherein the center of the observation window is closer to a center of the distal end surface than the center of the first illumination window (Objective Lens is closer to the middle than the peripheral Light).
Regarding Claim 21, Lwin further discloses wherein a front water supply port (WJ) is provided on the distal end surface, and in the first direction, a center of the front water supply port (WJ) is disposed between the center of the observation window (objective lens) and the center of the second treatment tool outlet port (auxiliary; see Fig. 7A).
Regarding Claim 22, Lwin further discloses wherein the center of the observation window is closer to a center of the distal end surface than the center of the front water supply port (the WJ is on the other side of the center such that the distance from the objective is closer to the center than the WJ as the line from the objective to the WJ passes the center of the distal end surface).
Regarding Claim 24, Lwin does not explicitly disclose wherein a second illumination window is provided on the distal end surface, and in the first direction, a center of the second illumination window is disposed between the observation window and the first illumination window. However, Lwin does disclose more than on light (see Fig. 7A) and, as stated above, rearranging parts has been held to be obvious if it does not change the overall function of the device (2144.04.VI.C (citing In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). It has also been held that duplicating parts is obvious (see MPEP 2144.04.VI.B citing In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)). Here, an additional light source can be added next to the first between the Light and the Air Nozzle or the Light and the Cautery opening. This can help improve the relative brightness in the body. Finally, the single light on the left can be made into multiple light fibers and be positioned along the objective. Light fibers are known to be of small diameter, and in the art, arranging light fibers near the objective is known for providing illumination. In any of these circumstances, having an additional light on the left side of the device would read on the claim. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Lwin’s device to include a second light on the left side near the first light as either a rearranging of existing lights or a duplication of existing lights as is known in the art for providing illumination at the distal end of the device.
Regarding Claim 25, Lwin as modified further discloses wherein the center of the observation window is closer to a center of the distal end surface than the center of the first illumination window and the center of the second illumination window (see Fig. 7A, the Light is on the perimeter of the Objective, see discussion above for claim 24 about adding another light to the perimeter).
Regarding Claim 26, Lwin does not explicitly disclose wherein in the second direction, the first illumination window, the observation window, and the second illumination window are arranged in this order. However, as discussed with claim 24, duplicating and rearranging parts are obvious. Here, an additional light source can be added between the air nozzle and grasper. This can help improve the relative brightness in the body. Light fibers are known to be of small diameter, and in the art, arranging light fibers near the objective is known for providing illumination. In either of these circumstances, having an additional light on the device would read on the claim. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Lwin’s device to include a second light as either a rearranging of existing lights or a duplication of existing lights as is known in the art for providing illumination at the distal end of the device.
Regarding Claim 27, Lwin as modified further discloses wherein in the second direction, the center of the first illumination window, the center of the observation window, the center of the first treatment tool outlet port, and the center of the second illumination window are arranged in this order (see rejections of claims 19 and 26 above, placing a second light just to the right of the air nozzle would satisfy the claimed arrangement and it is considered obvious to make slight adjustments to the relative locations of the first illumination window and observation window).
Regarding Claim 28, Lwin does not explicitly disclose wherein the first direction is along an up/down direction of an image based on electrical signals from an image sensor that receives light incident through the observation window. However, rotating the device 90 degrees gives this configuration (see below). The Grasper opening and the Aux opening would be in the proper location relative to the light and observation windows.
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Regarding Claim 29, Lwin as modified further discloses wherein the first illumination window, the observation window, the second treatment tool outlet port, and the first treatment tool outlet port are arranged in this order from top in the up/down direction (see rejection of Claim 28 and image directly above; 1 is above 2, 2 above 3, and 3 above 4 from top to bottom).
Regarding Claim 30, Lwin as modified further discloses wherein the second direction is along a left/right direction of the image (see rejection of claim 28, with the reorientation, the Aux opening 3, Objective Lens 2, and Grasper 4 are in order as claimed).
Allowable Subject Matter
Claim 23 is 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.
The following is a statement of reasons for the indication of allowable subject matter:
The primary reason the claims are allowable over the prior art is that the prior art fails to disclose or render obvious the claimed location of the water supply port relative to the treatment tool outlet ports. Lwin’s second direction is vertical, and the water port sits directly between the two tool ports. While rearranging parts can be considered obvious, there are limits. Here, if the air nozzle were also used for water, then the center of the observation window would be closer to the center of the water port than the center of the distal end surface (see Fig. 7A). Maybe the air nozzle can be used for water, but it would also have to be moved, perhaps along with the observation window, to have the claimed configuration. At some point, such modifications are no longer obvious and are simply an act of hindsight reasoning. The Examiner thinks for claim 23, that point has been reached. Without some clear teaching to make the necessary changes, there is no proper rationale for modifying Lwin to render to the claim obvious. That teaching has not been found, so the claim overcomes the prior art.
Response to Arguments
Applicant's arguments filed August 24, 2026, have been fully considered but they are not persuasive.
The Examiner has tried to clarify the application of Lwin above, and notes that Lwin’s configuration as set forth above, reads on the claim. The Examiner does not consider the claimed subject matter to have unexpected results as Lwin also allows for multiple tools to be inserted to a target site while being imaged to improve accuracy. This is standard in the art and is the reason cameras are used. Imaging the target site while working on it provides accuracy to the procedure.
The claims remain rejected as set forth above, and the application is not in condition for allowance at this time.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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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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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795
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