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 .
DETAILED ACTION
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, 21, 22 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 by an electrically insulating resin layer which 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 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 by an electrically insulating resin layer which 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 21, “The endoscope according to claim 1, wherein the camera driver is configured to perform image pre-processing to convert signals from the image sensor into information packets (output signal from the imaging device 10 is amplified by an amplifier circuit formed on the substrate 11 and is connected to a monitor device through a signal processing circuit behind by a code 13 passing through the shield cable 12; fig 2)”.
Iwata discloses for claim 22, “The endoscope according to claim 1, wherein the flexible sheath is a tube (fig 2)”.
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 a 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 shielding 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, 23 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 Kohler 20180035873 and Schultheis 20210022588.
Iwata does not disclose for claim 10, “The endoscope according to one of claim 1, wherein interference suppression capacitors having capacitances between 1 nF and 100 nF are electrically arranged between the protective sheath and electrical earth to limit a leakage current of the endoscope head is at most 50 μA”. Kohler and Schultheis teach in the same field of endeavor, specifications for components involved in controlling noise suppression and leakage currents. Kohler describes a capacitance C2 for a shielding 14 and housing 25 as preferably 10 nF (0042) while Schultheis describes such electrical shielding and patient leakage currents for applications at the heart have a maximum leakage current of 10 microA corresponding to CF classification (0013). 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 Kohler and Schultheis into the invention of modified Iwata in order to configure the endoscope e.g. as claimed because it provides adherence to a standard specification for maximum leakage currents generally (Kohler: 0020) and also classification for more specific cardiac related applications (Schultheis: 0013).
Iwata does not disclose for claim 23, “The endoscope according to claim 1, wherein the endoscope comprises electrical lines for supplying power to the camera and/or for transmitting image data, which extend to a proximal end of the endoscope, such that image information and camera control signals generated by the camera are transferred via galvanic isolation”. Kohler teaches in the same field of endeavor, providing galvanic barrier/isolation between endoscopic elements and the patient in order to protect the patient (galvanic barrier 15; 0003, 0042). 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 Kohler into the invention of Iwata in order to configure the endoscope e.g. as claimed because it provides protection for the patient (0003).
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 flexible 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 US20130096377.
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)”.
Response to Arguments
Applicant's arguments filed 5/20/2026 have been fully considered but they are not persuasive.
Argument 1: Applicant argues Iwata does not disclose the claimed camera driver, citing that Iwata’s element 11 is an amplifier circuit and attempts to distinguish this element from the invention by stating “In contrast, claims 1 and 17 recite an endoscope head having an image sensor and a camera driver arranged within a protective sheath” (page 5) and concluding from this statement, “The Office Action has not established that the simple amplifier circuit of Iwata teaches or suggests the camera driver arrangement as recited in the claimed context”. The conclusion is based on the assertion that the arrangement is not disclosed, i.e. “an endoscope having an image sensor and a camera driver arranged within a protective sheath”, but the particulars of the arrangement has been disclosed by Iwata and cited in the rejection, i.e. the image sensor (image sensor 10) and the protective sheath (cylinder body 15) with the camera driver and shown in the figures. As such it is unclear what this argument is attempting to rebut since the disclosure of the “arrangement” of the elements has been established.
Applicant mentions prior to this that “The Office Action alleges that the amplifier circuit (11) on the substrate of Iwata is equivalent to the recited camera driver”, but does not appear to provide arguments against this specific Office Action allegation or is disputing this point, but rather argues against the “arrangement” of the components as responded to above. As such, since this point (equivalency of the amplifier circuit and camera driver) was not specifically argued against it is interpreted as Applicant’s concurrence that this allegation is valid. Disregarding the discontinuity of applicant’s argument and supporting statements, if applicant is granted the benefit of doubt and the argument is interpreted as Iwata’s element 11 not reading on the claimed “camera driver”, this is also not persuasive. The claim does not further provide a defining scope for what a “camera driver” is. When confronted with this situation, what this term generally refers to in the context of the art must considered but also the claim term must be read in light of the specification. As such, referring to applicant’s own specification at page 6 line 22, it states “In the simplest case, the camera driver is a circuit board that is attached to the camera”. This statement appears then to be the clearest guidance as to further defining the scope of this element and to determine how and if Iwata’s element 11 reads on it. Disregarding applicant’s mischaracterization of this element as “specifically as an amplifier circuit for performing signal amplification” (the camera driver was cited as “amplifier circuit/substrate 11), Iwata’s element 11 clearly reads on the claimed “camera driver” in light of the specification, i.e. “a circuit board” which is considered to be a substrate. As such, it appears even given the benefit of doubt, applicant’s argument seeks to impart a narrower scope or interpretation of “camera driver” than provided in the specification, but additional does not even provide further details of the narrower scope interpretation, i.e. how the “camera driver” explicitly is different from element 11, other than to mention an “arrangement” with other components.
Argument 2: applicant argues that the cited art does not disclose the insulation arrangement of claim 1. As disclosed in the rejection the insulating cover 7 is cited as the flexible sheath which is and forms the insulation. The insulation cover 7 completely covers the cylinder body 15 as seen in fig 2 of Iwata.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
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 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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/Jae Woo/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
8/23/26
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