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:
“optical module” and details thereof in claims 2-4, 18-20;
“resin layer” in claim 4;
“the protective sheath is connected at its proximal end to an electrically conductive plastic body with an earth-related cable” in claim 7 (it is unclear if/where these are depicted and which elements they are as they are not included in the list of Reference Signs at the end of the specification, e.g. the listing includes “9 electrical cables” and “27 shielding cables”, but no “earth-related cable” or “plastic body”);
the subject matter of claim 8 is not shown, i.e. how the flexible sheath “can be bent into a circle with a radius of at least not more than 3 cm”. Applicant is requested to provide a drawing which demonstrates this as it is unclear what this means;
“image sensor” in claim 17;
must be shown or the feature(s) canceled from the claim(s). 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.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show, in particular fig 3, the details of at least the protective sheath 15 and sheathing 17, sheath 17, and insulation 17, along with shield 16, screen 16, resin layer 18, epoxy sealant 18 as described in the specification. Fig 3 is a fuzzy drawing which does not adequately show multiple planar elements which are configured very close to each other. A more detailed figure as a proper line drawing is required, including a closer/zoomed view of the planar elements. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
Specification
The disclosure is objected to because of the following informalities:
The specification takes great liberties when naming and addressing claim elements to the extent that potential 112a issues could be interpreted as
The specification’s use of names and reference characters is inconsistent and could amount to potential 112a issues, e.g. protective sheath 15 and sheathing 17, sheath 17, and insulation 17, along with shield 16, screen 16, resin layer 18, epoxy sealant 18, plastic body (which lacks a reference character). The complete specification should be reviewed for such errors.
Appropriate correction is required.
Claim Rejections - 35 USC § 112b
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.
Claims 3, 4, 8, 10, 11, and any dependent claims are 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 3 recites the limitation "distal end regions of optical fibers". There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites “the optical module is surrounded in the opening direction by an electrically insulating resin layer”. It is unclear what “in the opening direction” is. It will be interpreted as “the optical module is surrounded by an electrically insulating resin layer”.
Claim 8 recites “the flexible sheath is flexible such that it can be bent into a circle with a radius of at least not more than 3 cm”. It is unclear what this means. It will be interpreted as “the flexible sheath is flexible such that it can be bent”.
Claim 10 recites “… capacitors … which are designed in such a way that a leakage current of the endoscope head is at most 50 microA …”. It is unclear what structural limitations are imposed by this requirement. It will be interpreted as being grounded through a capacitor.
Claim 11 recites “the sheath is at least 1 m”. Multiple sheaths have been recited and therefore, this reference to the sheath is indefinite.
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.
Claim(s) 1, 2, 4, 6, 8, 12, 17, 18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwata JPS63155016 and further in view of Kinomoto US20220071602.
Iwata discloses for claim 1, “An endoscope for cardio-float applications comprising an endoscope head (fig 2) and a flexible sheath (insulating cover 7), wherein a camera (image sensor 10 and amplifier circuit/substrate 11) with distal viewing direction is arranged in the endoscope head, wherein the endoscope head has a shielding, earth-related, electrically conductive protective sheath (cylinder body 15; specification describes body 15 is grounded via ground wire 20 of the shield cable 12 to prevent noise), within which an image sensor (image sensor 10) and a camera driver (amplifier circuit/substrate 11) are arranged”.
Iwata does not disclose “and has an insulation which completely encloses at least the protective sheath and has a breakdown voltage of at least 1 kV, wherein the flexible sheath forms the insulation”. Iwata simply does not specify the actual voltage level. Kinomoto teaches in the same field of endeavor, insulation dielectric breakdown voltages greater than or equal to 2kV for endoscopic applications (0149). Since Iwata fails to disclose the specific breakdown voltage, 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 suitable voltage known in the art, including the one taught by Kinomoto, to achieve the predictable result of providing an insulation.
Iwata discloses for claim 2, “The endoscope according to claim 1, wherein the camera has an optical module (optical module 22 with lenses 21) which is coupled to the image sensor”.
Iwata discloses for claim 4, “The endoscope according to claim 2, wherein the optical module is surrounded in the opening direction by an electrically insulating resin layer which preferably connects the optical module to an inner surface of the flexible sheath (insulating cover 3; fig 2; the specification describes the front end portion 22b of the lens frame 22 is fitted into a hole bored in the insulating cover 3, and the most advanced objective lens 21b is inserted into the hole is exposed on the surface of the insulating cover 3)”.
Iwata discloses for claim 6, “The endoscope according to claim 1, wherein the camera driver is designed to perform image preprocessing (amplifier circuit/substrate 11)”.
Iwata discloses for claim 8, “The endoscope according to claim 1, wherein the flexible sheath is flexible such that it can be bent into a circle with a radius of at least not more than 3 cm (per the provided interpretation above, insulating cover 7 is described in the specification as made of flexible and electrically insulating rubber)”.
Iwata discloses for claim 12, “The endoscope according to one of claim 1, wherein the breakdown voltage is at least 2 kV, preferably at least 4 kV and in particular at least 6 kV (Kinomoto: 0149)”.
Iwata discloses for claim 17, “An endoscope for cardio-float applications, comprising:
an endoscope head (fig 2);
a camera (image sensor 10 and amplifier circuit/substrate 11) with distal viewing direction in the endoscope head and including an image sensor and a camera driver;
a protective sheath (cylinder body 15) providing earth-related electrically conductive shielding for the endoscope head, within which the image sensor and the camera driver are arranged (fig 2); and
a flexible sheath (insulating cover 7) completely enclosing at least the protective sheath (fig 2).
Iwata does not disclose “having a breakdown voltage of at least 1 kV”. Iwata simply does not specify the actual voltage level. Kinomoto teaches in the same field of endeavor, insulation dielectric breakdown voltages greater than or equal to 2kV for endoscopic applications (0149). Since Iwata fails to disclose the specific breakdown voltage, 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 suitable voltage known in the art, including the one taught by Kinomoto, to achieve the predictable result of providing an insulation.
Iwata discloses for claim 18, “The endoscope according to claim 17, wherein that the camera has an optical module (optical module 22 with lenses 21) which is coupled to the image sensor (fig 2)”.
Iwata discloses for claim 20, “The endoscope according to claim 18, wherein the optical module is surrounded in the opening direction by an electrically insulating resin layer which preferably connects the optical module to an inner surface of the flexible sheath (insulating cover 3; fig 2; the specification describes the front end portion 22b of the lens frame 22 is fitted into a hole bored in the insulating cover 3, and the most advanced objective lens 21b is inserted into the hole is exposed on the surface of the insulating cover 3)”.
Claim(s) 3, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwata and Kinomoto as applied to claim 2 above, and further in view of Wada US 20150365571.
Iwata discloses for claim 3, “The endoscope according to claim 2, wherein the distal end region of the optical module is arranged outside the protective sheath (fig 2)”
Iwata does not disclose “so that distal end regions of optical fibers for illuminating a field of view are arranged adjacent to the optical module”. Wada teaches in the same field of endeavor, providing optical fibers 52 for illumination to the distal end of an endoscope (fig 6). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Wada into the invention of Iwata in order to configure the endoscope e.g. as claimed because it provides direct illumination to the end of the endoscope where the image sensor resides.
Iwata discloses for claim 19, “The endoscope according to claim 18, wherein that the distal end region of the optical module is arranged outside the protective sheath (fig 2)”.
Iwata does not disclose “so that distal end regions of optical fibers for illuminating a field of view are arranged adjacent to the optical module”. Wada teaches in the same field of endeavor, providing optical fibers 52 for illumination to the distal end of an endoscope (fig 6). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Wada into the invention of Iwata in order to configure the endoscope e.g. as claimed because it provides direct illumination to the end of the endoscope where the image sensor resides.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwata and Kinomoto as applied to claim 1 above, and further in view of Lei US20150312451.
Iwata does not disclose for claim 5, “The endoscope according to claim 1, wherein the image sensor is an area sensor with preferably at least 150×150 pixels”. Iwata lacks the disclosure indicating a specific size of the image sensor. Lei teaches in the same field of endeavor, providing a various sizes of image sensors including 280 x 280 (0052). Since Iwata fails to disclose the specific image sensor size, 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 suitable size known in the art, including the one taught by Lei, to achieve the predictable result of providing a viable image sensor.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwata and Kinomoto as applied to claim 1 above, and further in view of Honda US 20080294005.
Iwata discloses for claim 7, “The endoscope according to one of claim 1, wherein the protective sheath is connected at its proximal end to an electrically conductive body (resin filler 19; fig 2) with an earth-related cable (ground wire 20)”.
Iwata does not disclose wherein the protective sheath is connected at its proximal end to an electrically conductive “plastic” body with an earth-related cable, i.e. where the body is plastic. Iwata does not specify the resin as containing plastic. Honda teaches in the same field of endeavor, “insulating region 13d is formed of a resin material such as a plastic” (0092), i.e. disclosing plastics as a particular resin material. Since Iwata fails to disclose the specific resin material, 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 suitable material known in the art, including the one taught by Honda, to achieve the predictable result of providing a resin.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwata and Kinomoto as applied to claim 1 above, and further in view of Cho US5083549.
Iwata does not disclose for claim 9, “The endoscope according to one of claim 1, wherein the diameter of the endoscope head is at most 3.5 mm, preferably at most 2.0 mm and in particular at most 1.2 mm”. Iwata simply lacks disclosure indicating a specific diameter. Cho teaches in the same field of endeavor, providing an endoscope with a diameter of 3 mm or less (1:57). Since Iwata fails to disclose the specific diameter, 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 suitable diameter known in the art, including the one taught by Cho, to achieve the predictable result of providing an endoscope with an viable diameter.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwata and Kinomoto as applied to claim 1 above, and further in view of Yabe US5536235.
Iwata does not disclose for claim 10, “The endoscope according to one of claim 1, wherein interference suppression capacitors are arranged between the protective sheath and the earth, which are designed in such a way that a leakage current of the endoscope head is at most 50 μA, preferably at most 25 μA and in particular preferably at most 10 μA”. Yabe teaches in the same field of endeavor, providing a capacitor to a sheath (tube cover exterior 131) to ground (17:5-13). Based on the provided interpretation above, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Yabe into the invention of Iwata in order to configure the endoscope e.g. as claimed because it provides a grounding effect for the noise so that currents are not sent to a patient even when a ground line is cut (17:5-13).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwata and Kinomoto as applied to claim 1 above, and further in view of Ewers US20080262300.
Iwata does not disclose for claim 11, “The endoscope according to one of claim 1, wherein the sheath is at least 1 m, preferably at least 1.5 m and in particular at least 2.5 m long”. Ewers teaches in the same field of endeavor, a steering section with a sheath 38 between 20-200 cm long (0033). Since Iwata fails to disclose the specific length, 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 suitable length known in the art, including the one taught by Ewers to achieve the predictable result of providing an endoscope with an viable length.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwata and Kinomoto as applied to claim 1 above, and further in view of Hornbach US20190020507.
Iwata does not disclose for claim 13, “An endoscope system comprising an endoscope according to claim 1 and a camera controller, wherein the camera controller has galvanically isolated electrical connections, including a power supply and data line, to the endoscope head”. Hornbach teaches in the same field of endeavor, galvanically isolating a camera controller 5 from elements of an endoscope (0063). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Hornbach into the invention of Iwata in order to configure the endoscope system e.g. as claimed because it adheres to standards relating to electrical safety of endoscopes (0063).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwata, Kinomoto, and Hornbach as applied to claim 13 above, and further in view of Cho.
Iwata does not disclose for claim 14, “The endoscope system according to claim 13, wherein the endoscope system has at least one working channel”. Cho teaches in the same field of endeavor, providing a working channel in an endoscope (6:9). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Cho into the invention of Iwata in order to configure the endoscope system e.g. as claimed because it allows access to a working site.
Claim(s) 15, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwata, Kinomoto, and Hornbach as applied to claim 13 above, and further in view of Duindam US 20130096377.
Iwata does not disclose for claim 15, “The endoscope system according to claim 13, wherein the endoscope system comprises Bowden cables for controlling the endoscope system during insertion into a human or animal cavity”. Duindam teaches in the same field of endeavor, providing a catheter 110 with Bowden cables for actuating tendons for steering (0019). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Duindam into the invention of Iwata in order to configure the endoscope system e.g. as claimed because it allows articulation and steering (0019).
Modified Iwata discloses for claim 16, “The endoscope system according to claim 15, wherein the Bowden cables are arranged in a catheter (110) formed separately from the endoscope (fig 2, 3; 0019)”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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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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/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
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