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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
Therefore, the “in the second direction, the second treatment tool outlet port, the observation window, and the first treatment tool outlet port are arranged in this order” (claim 1) must be shown or the feature(s) canceled from the claim(s). As discussed in more detail below, the Drawings (see Figs. 2-3) show the second treatment tool outlet port, the first treatment tool outlet port, and the observation window in this order.
Claim 26 requires the first illumination window, the observation window, and the second illumination window to be aligned in the second direction. This is not shown.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
Claims 1 and 15-30 are 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 1 was amended after the initial filing on September 30, 2024. The amended claim requires “in the second direction, the second treatment tool outlet port, the observation window, and the first treatment tool outlet port are arranged in this order”. As shown below, the order in the second direction (the horizontal direction left to right) is the second treatment tool outlet port 54, the first treatment tool outlet port 52, and then the observation window 46.
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Because this amendment is not part of the original disclosure, it must be fully supported by the original disclosure and not contain new matter. This limitation is not fully supported and is, therefore, new matter. A person having ordinary skill in the art would not consider Applicant to have been in possession of the claimed subject matter at the time of filing.
Claim 22 requires “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 water supply port is 56. The Examiner does not see any discussion of the relative position of 56 to C and to 46A. The Drawings are not sufficiently clear that 46A is closer to C than to 56A. The claim is not directed to the air/water supply nozzle, which may or may not have support for such a claim. Therefore, a person having ordinary skill in the art would not consider Applicant to have been in possession of the claimed subject matter at the time of filing.
Claim 26 requires the first illumination window, the observation window, and the second illumination window to be aligned in the second direction. This is not shown in the Drawings or described in the Specification. Therefore, a person having ordinary skill in the art would not consider Applicant to have been in possession of the claimed subject matter at the time of filing.
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 19 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 19 depends from claim 1. Claim 1 requires “in the second direction, the second treatment tool outlet port, the observation window, and the first treatment tool outlet port are arranged in this order.” Claim 19 requires “in the second direction, the first treatment tool outlet port, the first illumination window, and the observation window are arranged in this order.” Claim 19 seems to contradict claim 1 because the first treatment tool outlet port is now in a different order relative to the observation window. In claim 1, the first treatment tool outlet port comes after the observation window. In claim 19, the first treatment tool outlet port comes before the observation window. This contradiction renders the claim indefinite as the Examiner does not know how the scope of the claim can encompass both configurations. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 20-22 are rejected under 35 U.S.C. 102a2 as being anticipated by 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 Cautery opening) which is provided on the distal end surface and out of which a second treatment tool is capable of being led (opening for a cautery device),
wherein
in the first direction (left to right in Fig. 7A, see below), the first illumination window (Light 1), the observation window (Objective Lens 2), the second treatment tool outlet port (Cautery 3), and the first treatment tool outlet port (Grasper 4) are arranged in this order (Fig. 7A shows this order, see below),
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and
in the second direction (down to up in Fig. 7A, see below), the second treatment tool outlet port (Cautery 1), the observation window (Objective Lens 2), and the first treatment tool outlet port (Grasper 3) are arranged in this order (this order is shown in Fig. 7A, see below).
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Regarding Claim 20, Lwin further discloses wherein a center of the observation window is closer to a center of the distal end surface than a center of the first illumination window (Objective Lens is closer to the middle than the peripheral Light).
For Claim 21, in an alternative rejection of claim 1, Lwin can be shown to have the Grasper as the second tool port and the Aux as the first. Going from left to right, the light, the objective, the grasper, and the Aux is shown in Fig. 7A. Going from down to up, the Aux, the objective, and the grasper is shown. With this application, 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 is disposed between a center of the observation window and a center of the second treatment tool outlet port (see Fig. 7A showing the WJ between the center of the objective and the Grasper going from left to right).
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).
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 15-18, 23-25, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Lwin et al. (US 2020/0315720).
Lwin discloses the invention substantially as claimed.
Regarding Claim 15, Lwin does not explicitly disclose wherein a distance between a center of the observation window and a center of the second treatment tool outlet port is longer than a distance between the center of the observation window and a center of the first treatment tool outlet port. 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 slightly more distance between the observation window and the second treatment tool outlet port than the first. Such a modification is a simple change in dimensions and/or requires little more than a slight positional change of components without changing the function of the device.
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, as stated above with claim 15, 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 discloses another channel (Aux) that can be used to receive forceps (Paragraph 0164). Swapping positions of the two channels would read on the claims. 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 modify Lwin’s diameters. 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 Cautery opening and the Aux opening would be in the proper location.
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As discussed above, rearranging parts without changing the function is considered obvious (see 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 device to have a different orientation. Such a modification does not change the principal function and is the mere rearranging of parts.
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 Cautery opening, Objective Lens, and Grasper are in order as claimed).
Regarding Claim 23, Lwin does not explicitly disclose wherein in the second direction, the second treatment tool outlet port, the first treatment tool outlet port, and the front water supply port are arranged in this order. However, an air nozzle is placed in this configuration. Either moving the WJ to the air nozzle position or making the air nozzle for air and water as is known in the art would then read on the claim. As to claim 22, as discussed above, making relative changes to dimensions such that having 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 would be 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) 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 modify Lwin’s device to have the nozzle located as discussed above. Such a modification does not change the function of the device and is merely making slight dimensional changes or rearranging parts.
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 a center of the observation window is closer to a center of the distal end surface than a 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 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 Cautery opening and the Aux opening would be in the proper location.
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As discussed above, rearranging parts without changing the function is considered obvious (see 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 device to have a different orientation. Such a modification does not change the principal function and is the mere rearranging of parts.
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 above, as shown the order remains the same).
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 Cautery opening, Objective Lens, and Grasper are in order as claimed).
Conclusion
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