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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/5/2026 has been entered.
Disposition of Claims
Claims 1-8 and 10-16 are pending.
Claim 9 is canceled.
Response to Amendment
The amendment filed on 6/5/2026 has been entered. Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Final Office Action mailed 3/11/2026. The claim interpretations invoked under 35 USC § 112(f) set forth in the Final Office Action mailed 3/11/2026 have been withdrawn due to Applicant’s amendments.
Response to Arguments
Applicant’s arguments, see Pages 8-13, filed on 6/5/2026, with respect to the rejections under 35 U.S.C. § 103 of Claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 5-7 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 5 recites the limitation "a housing chamber" in line 5. Claim 1 introduces a housing chamber. It is unclear if the applicant is referring to the housing chamber presented in claim 1 or another additional housing chamber. For the purposes of examination, “a housing chamber” is being interpreted as “the housing chamber.”
Claims 6-7 are rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0297193 A1 to Takahashi et al. (“Takahashi”) in view of U.S. Patent Appl. Publ. No. 2018/0278816 A1 to Yoneyama (“Yoneyama”) and U.S. Patent Appl. Publ. No. 2021/0121045 A1 to Levy et al. (“Levy”).
Regarding claim 1, Takahashi discloses an endoscope (an endoscope 1; Fig. 1, paragraph 0020) comprising:
an insertion pipe that is to be inserted into a subject (an insertion section 9; Fig. 1, paragraph 0020);
a distal end portion body that is disposed at a distal end of the insertion pipe (a distal end portion 9A of an insertion section 9; Fig. 1, paragraph 0020) and includes a housing chamber (substantially cylindrical housing 10 is disposed in the distal end portion 9A of the insertion section 9; Fig. 2, paragraph 0021) in which an imaging unit is held (image pickup device 2; Fig. 2, paragraph 0021), a lens cover for covering the imaging unit (distal end lens 21; Fig. 2, paragraph 0027), and sealing member disposed between the imaging unit and the lens cover, wherein the lens cover directly contacts the sealing member which directly contacts an opening portion of the housing chamber (the distal end lens 21 inserted into the through hole H10 from a front side (object side) through hole H10 is directly fixed to the housing 10 using an adhesive agent, glass, or solder, for example; Fig. 2, paragraph 0027); and
the imaging unit that is housed and held in the housing chamber in an attachable (the image pickup device 2 is inserted into and fixed to the through hole H10; Fig. 2, paragraph 0021) and detachable manner (the image pickup device 2 excluding the distal end lens 21 can be easily pulled out backward from the housing 10; Fig. 4, paragraph 0034) in an airtight or liquidtight state with respect to an external space as the sealing member maintains the airtight or the liquidtight state with respect to the external space (the distal end lens 21 is watertightly fixed to a distal end portion of the through hole H10 in the housing 10; Fig. 2, paragraphs 0026-0027),
wherein the imaging unit has an image sensor (the image pickup unit 30 converts an object image converged by the optical unit 20 into an electrical signal. The image pickup unit 30 includes an image pickup element 31, a cover glass 32, a signal processing unit 33, and a signal cable 35; Fig. 3, paragraph 0029).
However, Takahashi does not explicitly disclose wherein the sealing member is an elastic film disposed between the imaging unit and the lens cover and wherein the image sensor observes a visual field region in a first direction perpendicular to an axial direction of the insertion pipe.
Yoneyama teaches wherein the sealing member is an elastic film disposed between the imaging unit and the lens cover (uncured liquid resin 30L is disposed between the light receiving surface 10SA in the image pickup device 10 and the second main surface 20SB in the cover glass 20 … Note that the resin 30L may be a flexible film; Fig. 2A, paragraph 0044). Yoneyama teaches that a flexible film resin helps provide reinforced adhesion to a lens cover during manufacturing of an endoscope (paragraph 0036).
Yoneyama is considered to be analogous to the claimed invention because it is in the same field of image pickup devices for endoscopes. While Takahashi does disclose a sealing member such as an adhesive agent disposed directly between the lens cover and the opening portion of the housing chamber, it does not explicitly disclose said adhesive agent comprising an elastic film. As the reference is not limited to any specific examples of adhesive agent and as an elastic film used as a sealing member with a lens cover was well known in the art at the time the invention was made, as evidenced by Yoneyama, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use any sealing member, including a sealing member comprising an elastic film in the endoscope of Takahashi. Said combination would amount to use of a known element for its intended use in a known environment to accomplish an entirely expected result.
Additionally, Levy teaches an image sensor that observers a visual field region in a first direction perpendicular to an axial direction of the insertion part (side looking viewing element 116b; Fig. 2B, paragraph 0475). Levy teaches that a side looking image sensor helps to gain better visualization of some objects that may be less visible with a front looking viewing element (paragraph 0475).
Levy is considered to be analogous to the claimed invention because it is in the same field of endoscopes with image sensors found at the distal end. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the viewing angle of the image sensor of Takahashi to incorporate the teachings of Levy by changing the viewing angle from parallel to the axial direction of the insertion part to perpendicular to the axial direction of the insertion part. Doing so would help to gain better visualization of some objects that may be less visible with a front looking viewing element, as recognized by Levy.
Regarding claim 2, Takahashi, as previously modified by Yoneyama and Levy, discloses the endoscope according to claim 1. Takahashi further discloses wherein the distal end portion body further includes:
a first opening portion that is positioned on a proximal end side of the housing chamber (proximal end of through hole H10; Fig. 3) as the imaging unit is separated from the housing chamber through the first opening portion in a case where the imaging unit held in the housing chamber is pulled toward a proximal end side of the distal end portion body (the image pickup device 2 excluding the distal end lens 21 can be easily pulled out backward from the housing 10 when the image pickup device 2 is replaced; Fig. 4, paragraph 0034).
Regarding claim 10, Takahashi, as previously modified by Yoneyama and Levy, discloses the endoscope according to claims 1-2. Takahashi, as modified by Levy for a change in orientation of the imaging unit and as modified by Yoneyama, further discloses wherein the imaging unit includes a chamfer portion that is inclined from an upper end surface facing the lens cover to a proximal end surface or from the upper end surface to a distal end surface (chamfer portion as indicated by a circle in annotated Fig. 9 below; Fig. 9), and
the imaging unit comes into contact with a distal end surface or a proximal end surface of the housing chamber or a corner portion of the housing chamber (corner portion of the housing 10 indicated by a square in annotated Fig. 9 below; Fig. 9) that is positioned diagonally opposite to the chamfer portion with the chamfer portion being pressed by an elastic force of the elastic film (chamfer portion indicated by a circle in annotated Fig. 9 below; Fig. 9).
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Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi, as previously modified by Yoneyama and Levy, as applied to claims 1-2 above, and further in view of U.S. Patent Appl. Publ. No. 2009/0259100 A1 to Ito et al. (“Ito ‘100”).
Regarding claim 3, Takahashi, as previously modified by Yoneyama and Levy, discloses the endoscope according to claims 1-2. Takahashi further discloses wherein the housing chamber includes a locking portion that locks the imaging unit (the unit frame 39 has a front portion inserted into the through hole H10, and an outer peripheral surface of the inserted front portion is bonded to the through hole H10 using an adhesive agent 40; Fig. 4, paragraph 0031), and
the imaging unit is allowed to move to the proximal end side in a case where the imaging unit is unlocked (although the housing 10 and the image pickup device 2 are bonded to each other using the adhesive agent 40, the adhesive agent 40 having a modulus of elasticity of 10 MPa or less can be easily fractured by a sheer stress; Fig. 4, paragraph 0034).
However, Takahashi, as modified by Yoneyama and Levy, does not explicitly disclose a locking claw.
Ito ‘100 teaches a locking claw (the connection unit 80 has a stopper (a lock) 82a to prevent removal of the imaging unit 100 from the connection unit 80… the lock 82a is a claw, for example, and prevents removal by locking in a groove 110a in the separate imaging connector; Fig. 8E, paragraph 0065).
Ito ‘100 is considered to be analogous to the claimed invention because it is in the same field of endoscopes with an endoscope main body and imaging unit that are freely connectable and separable. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have substituted the adhesive of Takahashi with the locking claw of Ito ‘100, because the substitution of art recognized equivalents as shown by Ito ‘100 is within the level of ordinary skill in the art. In addition, the substitution of one locking mechanism for another is likely to be obvious when it does no more than yield predictable results.
Regarding claim 4, Takahashi, as previously modified by Yoneyama, Levy, and Ito ‘100, discloses the endoscope according to claims 1-3. Takahashi, as modified by Ito ‘100, teaches wherein the locking claw locks a proximal end surface of the imaging unit (the connection unit 80 has a stopper (a lock) 82a to prevent removal of the imaging unit 100 from the connection unit 80… the lock 82a is a claw, for example, and prevents removal by locking in a groove 110a in the separate imaging connector; Fig. 8E, paragraph 0065).
Claims 5, 11-12, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi, as previously modified by Yoneyama and Levy, as applied to claims 1-2 above, and further in view of U.S. Patent Appl. Publ. No. 2021/0259532 A1 to Ito et al. (“Ito ‘532”).
Regarding claim 5, Takahashi, as previously modified by Yoneyama and Levy, discloses the endoscope according to claim 1. Takahashi, as modified by Yoneyama and Levy, does not explicitly disclose wherein the distal end portion body further includes:
a second opening portion at which the lens cover is held in an attachable and detachable manner; and
the imaging unit is separated from the housing chamber through the second opening portion in a case where the lens cover held at the second opening portion is removed and the imaging unit held in the housing chamber is pulled toward the second opening portion.
Ito ‘532 teaches wherein the distal end portion body includes:
a lens cover through which at least a portion of the imaging unit is exposed (behind the window plate 145, an observation window 132 and two illumination windows 133 arranged on the left and right sides of the observation window 132 are provided; Fig. 3, paragraph 0049);
a second opening portion at which the lens cover is held in an attachable (the window 145 is fitted into the window plate frame 75 and attached to the distal tip frame 70 by any means such as bonding or ultrasonic welding; Fig. 3, paragraph 0053) and detachable manner (the window plate is removed from the distal tip frame 70; Fig. 20, paragraph 0113); and
a housing chamber in which the imaging unit is held (the imaging/cable unit 15 is fixed to the distal tip frame 70 by a fixing screw 69 screwed into the communication hole 712; Fig. 3, paragraph 0057), and
the imaging unit is separated from the housing chamber through the second opening portion in a case where the lens cover held at the second opening portion is removed and the imaging unit held in the housing chamber is pulled toward a second opening portion (the imaging/cable unit 15 can be taken out from the endoscope 10 by pulling the claw jig 82; Fig. 20-23, paragraphs 0113-0117). Ito teaches the use of jigs for removing the imaging unit without pulling on the cable assembly helps to prevent damaging the cable assembly (paragraph 0123).
Ito ‘532 is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a distal end body and imaging unit that are freely connectable and separable. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of removing the imaging unit of Takahashi, as modified by Yoneyama and Levy, to incorporate the teachings of Ito ‘532 by using jigs to first remove the lens cover and then the imaging unit through the hole where the lens cover was housed. Doing so would help to prevent damaging the cable assembly, as recognized by Ito ‘532.
Regarding claim 11, Takahashi, as previously modified by Yoneyama and Levy, discloses the endoscope according to claims 1-2. Takahashi further discloses a cable connected to the imaging unit (signal cable 35; Fig. 2, paragraph 0020). However, Takahashi, as modified by Yoneyama and Levy, does not explicitly disclose a relay connector that is coupled to the imaging unit and a cable that is connected to the imaging unit via the relay connector, wherein the relay connector is disposed inside the distal end portion body.
Ito ‘532 teaches a relay connector that is coupled to the imaging unit (the imaging/cable unit 15 is configured by connecting a cable assembly 50 … and an imaging unit 60; Fig. 11, paragraph 0079); and
a cable that is connected to the imaging unit via the relay connector (cable bundle 51; Fig. 11, paragraph 0080),
wherein the relay connector is disposed inside the distal end portion body (cable assembly 50 is disposed inside distal tip frame 70; Fig. 20). Ito teaches that the cable assembly helps to create a strong connection state (paragraph 0101).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cable of Takahashi, as modified by Yoneyama and Levy, to incorporate the teachings of Ito ‘532 by using a relay connector to connect the cable to the imaging unit. Doing so would help to create a strong connection state, as recognized by Ito ‘532.
Regarding claim 12, Takahashi, as previously modified by Yoneyama and Levy, discloses the endoscope according to claims 1-2. Takahashi, as modified by Yoneyama and Levy, does not explicitly disclose wherein the lens cover is fixed to the distal end portion body, and the distal end portion body includes a jig cutout portion that adjoins the lens cover, for insertion of a jig that unfixes the lens cover.
Ito ‘532 teaches wherein the lens cover is fixed to the distal end portion body (the window plate 145 is fitted into the window plate frame 75 and attached to the distal tip frame 70 by any means such as bonding or ultrasonic welding; Fig. 3, paragraph 0053), and
the distal end portion body includes a jig cutout portion that adjoins the lens cover, for insertion of a jig that unfixes the lens cover (the window plate 145 is removed from the distal tip frame 70. This work is carried out, for example, by inserting a jig into the gap between the edge of the window plate 145 and the edge of the window plate frame 75 described with reference to Fig. 2, and picking the gap; paragraph 0113). Ito teaches that removing the lens cover allows the imaging/cable unit to be removed from the distal end side opening (paragraph 0113-0117).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lens cover of Takahashi, as modified by Yoneyama and Levy, to incorporate the teachings of Ito ‘532 by removing the lens cover with a jig. Doing so would help to allow the imaging/cable unit to be removed from the distal end side opening, as recognized by Ito ‘532.
Regarding claim 15, Takahashi, as previously modified by Yoneyama and Levy, discloses the endoscope according to claim 1. Takahashi, as modified by Yoneyama and Levy, does not explicitly disclose wherein the imaging unit includes a light source that irradiates a subject with illumination light.
Ito ‘532 teaches wherein the imaging unit includes a light source that irradiates a subject with illumination light (light emitting element 136 to illuminate a predetermined range; Fig. 6, paragraph 0060).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a light source in the endoscope of Takahashi, as modified by Yoneyama and Levy, as taught by Ito ‘532, in order to improve visualization, i.e. brightness of the image, with the Takahashi endoscope by illuminating the area being observed.
Regarding claim 16, Takahashi, as previously modified by Yoneyama and Levy, discloses the endoscope according to claim 1. Takahashi, as modified by Yoneyama and Levy, does not explicitly disclose wherein at least a portion of the endoscope is disposable except the imaging unit.
Ito ‘532 teaches wherein at least a portion of the endoscope is disposable except the imaging unit (it is possible to provide an endoscope 10 in which the imaging unit 60 can be reused. By reusing expensive components, a high-definition single-use endoscope 10 can be provided at low cost; paragraph 0121). Ito ‘532 teaches that reusing the imaging unit and not the rest of the endoscope helps to provide an endoscope assembly at a low cost (paragraph 0123).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscope of Takahashi, as modified by Yoneyama and Levy, to incorporate the teachings of Ito ‘532 by reusing the imaging unit and disposing of the rest of the endoscope. Doing so would help to provide an endoscope at a low cost, as recognized by Ito ‘532.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Takahashi, as previously modified by Yoneyama and Levy, as applied to claims 1-2 above, and further in view of Japanese Patent Pub. No. 2008043361 A to Honda (“Honda”).
Regarding claim 8, Takahashi, as previously modified by Yoneyama and Levy, discloses the endoscope according to claim 1. However, Takahashi, as modified by Yoneyama and Levy, does not explicitly disclose wherein the insertion pipe is composed of a distal end portion including the distal end portion body, a bendable portion installed consecutively to the distal end portion, and a soft portion installed consecutively to the bendable portion,
the distal end portion body further includes:
an engaging claw that engages in an attachable and detachable manner with the bendable portion or a fixing member fixed to the bendable portion, and
the imaging unit is separated, integrally with the housing chamber, from the bendable portion or the fixing member in a case where the engaging claw is disengaged from the bendable portion or the fixing member.
Honda teaches wherein the insertion pipe is composed of a distal end portion including the distal end portion body (a distal end rigid part 8; Fig. 1, paragraph 0022), a bendable portion installed consecutively to the distal end portion (a bending portion 9; Fig. 1, paragraph 0022), and a soft portion installed consecutively to the bendable portion (the distal end side guide tube 13; Fig. 1, paragraph 0022),
the distal end portion body includes:
a holding portion in which the imaging unit is held (the imaging unit 27 includes a substantially annular holding ring 28a; Fig. 11, paragraph 0035); and
an engaging claw that engages in an attachable and detachable manner with the bendable portion or a fixing member fixed to the bendable portion (a locking portion 60a, which is a locking means 60, is formed on the proximal end side of the connecting portion 26A of the distal end portion 8, while locking portion 6a is engaged with the distal side of the insertion portion 6A (curved portion 9); Fig. 9 and 11, paragraph 0095), and
the imaging unit is separated, integrally with the holding portion, from the bendable portion or the fixing member in a case where the engaging claw is disengaged from the bendable portion or the fixing member (the imaging unit 27 is separated, integrally with the holding ring 28a, when the locking portion 60a is disengaged from locking groove 60b on the bending portion 9; Fig. 9 and 11). Honda teaches the use of the engaging claw to help provide an endoscope tip which can be easily attached to the insertion portion while securing a sterilized state sufficiently (paragraph 0015).
Honda is considered to be analogous to the claimed invention because it is in the same field of endoscopes with an insertion section and imaging unit that are freely connectable and separable. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of removing the imaging unit of Takahashi, as modified by Yoneyama and Levy, to incorporate the teachings of Honda by using an engaging claw to attach the imaging unit to the insertion portion of the endoscope. Doing so would help to provide an endoscope tip which can be easily attached to the insertion portion while securing a sterilized state sufficiently, as recognized by Honda.
Allowable Subject Matter
Claims 6-7 and 13-14 are 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:
Regarding claim 6, Takahashi, as previously modified by Yoneyama, Levy, and Ito ‘532, discloses the endoscope according to claims 1 and 5. However, Takahashi, as modified by Yoneyama, Levy, and Ito ‘532, fails to explicitly disclose wherein the distal end portion body further includes a rail portion that is slidably fitted to a side edge of the lens cover, and the lens cover is disposed at a position facing the imaging unit in a case where the side edge of the lens cover is fitted to the rail portion.
Regarding claim 13, Takahashi, as previously modified by Levy and Yoneyama, discloses the endoscope according to claims 1 and 8. However, Takahashi, as modified by Levy and Yoneyama, fails to explicitly disclose wherein the housing chamber includes a locking claw that locks the imaging unit,
the distal end portion body includes an unlocking hole that communicates with the housing chamber, and
the imaging unit is unlocked or at least a portion of the locking claw is removed in a case where a jig is inserted through the unlocking hole to press the locking claw.
Additionally, there is no reason, teaching, or suggestion provided with any prior art of record to modify the above endoscope to have the above features.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
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/OLIVIA GRACE STARKEY/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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