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 .
Response to Amendment
The cancellation of claim 18 and 23, the addition of claims 26-29, and the amendments to claims 1, 4, 8, 13, 14, 16, 19, 22, and 24 in the response filed on 06/08/2026 are acknowledged.
Claims 1, 3-9, 11-14, 16, 19, and 21-29 remain pending in the application
Claims 2, 10, 15, 17, 18, 20, 23 are cancelled.
Claim 13-14 are withdrawn
Claims 1, 3-9, 11-12, 16, 19, and 21-29 are examined.
Response to Arguments
The applicant’s arguments have been considered but are moot in view of the new grounds of rejection necessitated by the applicant’s amendments to the claims. The applicant has modified claim 1 and 19 to require “an insertion apparatus to be inserted into a subject… wherein the first opening is provided at the distal end portion…and wherein the liquid located in the space when the insertion apparatus is inserted into the subject is either supplied to the subject or suctioned from the subject through the first opening”, limitations heretofore not presented for examination in this application. As such, the scope of the claims was substantially changed and new grounds for rejection are presented.
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.
Claim 1 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 1, 19, 22, and 29 recites “wherein, when the insertion apparatus is inserted into the subject, a liquid is located in the space, and wherein the liquid located in the space when the insertion apparatus is inserted into the subject is either supplied to the subject or suctioned from the subject through the first opening.” This is unclear as the claim does not clearly state how the liquid functions in the space. It is unclear if the insertion apparatus is inserted first and then the liquid flows in, or if liquid is in the space and then the insertion apparatus is inserted. The examiner suggests using “configured to” language to clarify the conditional liquid limitation.
Claims 3-9, 11-12, 16, 18, and 21, and 23-28 are similarly rejected by virtue of their dependency upon claims 1, 19, and 22.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP6599996B2 to Nakagawa.
Regarding claim 29, Nakagawa, discloses an insertion apparatus, comprising: an insertion portion (60, Fig. 4, [0059]) including: a first conduit having a first opening (51, Fig. 4, [0017]), wherein the first conduit is in fluid communication with an outside of the insertion portion via the first opening (Fig. 4), an illumination chamber having a second opening (1x, Fig. 3, [0052]), wherein the illumination chamber is configured to fluidly communicate with a peripheral part of the first conduit via the second opening(15A, Fig. 3, [0044]), an optical fiber configured to guide and radiate an illumination light (10, Fig. 3, [0019]), wherein a distal end of the optical fiber is located inside of the illumination chamber (Fig. 3), wherein the optical fiber is a non- hollow optical fiber (10), and an illumination lens provided distally relative to the distal end of the optical fiber (30A3, Fig. 3, [0049]), wherein the illumination lens is configured to radiate the illumination light to the outside of the insertion portion ([0049]), wherein the illumination lens includes an illumination window (30A3, Fig. 3, [0049]), wherein the illumination window is spaced apart from the distal end of the optical fiber to form a space between the illumination window and the distal end of the optical fiber (Fig. 3 the part inside of 15A), and wherein, when the insertion apparatus is in use, a liquid is located in the space (the examiner notes that this is a conditional limitation).
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.
Claim(s) 1, 4, 8, 9, 11, 12, 16, 19, 23, 24, 25, 26, 27, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP6599996B2 to Nakagawa in view of U.S. Publication No. 2019/0059701 to Igarashi.
Regarding claim 1, Nakagawa discloses an insertion apparatus to be inserted into a subject, the insertion apparatus comprising: an insertion portion (60, Fig. 4, [0059]) including: a distal end portion (distal end of 60), a first conduit having a first opening (51, Fig. 4, [0017]), an illumination chamber having a second opening (1x, Fig. 3, [0052]), wherein the illumination chamber is configured to fluidly communicate with a peripheral part of the first conduit via the second opening (15A, Fig. 3, [0044]), an optical fiber configured to guide and radiate an illumination light (10, Fig. 3, [0019]), wherein a distal end of the optical fiber is located inside of the illumination chamber (Fig. 3), and an illumination lens provided distally relative to the distal end of the optical fiber (30A3, Fig. 3, [0049]), wherein the illumination lens is configured to radiate the illumination light to the outside of the insertion portion ([0049]), wherein the illumination lens incl---udes an illumination window (30A3, Fig. 3, [0049]), wherein the illumination window is spaced apart from the distal end of the optical fiber to form a space between the illumination window and the distal end of the optical fiber (Fig. 3 the part inside of 15A), wherein, when the insertion apparatus inserted into the subject, a liquid is located in the space (The examiner notes that this is a conditional limitation) and wherein the liquid located in the space when the insertion apparatus is inserted into the subject is either supplied to the subject or suctioned from the subject through the first opening (The examiner notes that this is a conditional limitation).
Nakagawa fails to expressly teach wherein the first opening is provided at the distal end portion and the first conduit is in fluid communication with an inside of the subject via the first opening.
However, Igarashi teaches of an analogous insertion apparatus (100) wherein the first opening is provided at the distal end portion and the first conduit is in fluid communication with an inside of the subject via the first opening (111).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nakagawa to utilize a first opening, as taught by Igarashi. It would have been advantageous to make the combination for the purpose of inserting a treatment tool ([0227] of Igarashi).
Regarding claim 4, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 1, wherein the first conduit is configured to suction the liquid through the first opening and toward a proximal end of the first conduit (The examiner notes that the liquid limitation is conditional (see claim 1)).
Regarding claim 8, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 1, wherein the first conduit includes a guide part configured to guide the liquid from the first conduit toward the illumination chamber (The examiner notes that the liquid limitation is conditional (see claim 1)).
Regarding claim 9, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 8, but Nakagawa, in view of Igarashi, fails to expressly teach wherein the guide part has an inclined surface provided around at least a portion of a periphery of the second opening.
However, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nakagawa, in view of Igarashi, so that the guide part has an inclined surface, since a change in shape of a component or device is generally recognized as being within the level of ordinary skill in the art MPEP2144.04(IV)(B).
Regarding claim 11, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 1, and Nakagawa further discloses wherein the illumination chamber is connected to an optical fiber conduit (10, 20A, Fig. 3), wherein portions of the optical fiber are located in the optical fiber conduit, and wherein a gap between an inner surface of the optical fiber conduit and the optical fiber is sealed to form a watertight structure (10, 20A, Fig. 3).
Regarding claim 12, Nakagawa in view of Igarashi, teaches the insertion apparatus according to claim 1, and Nakagawa further discloses wherein the illumination chamber includes an inner surface (1x, Fig. 3, [0052]), wherein the optical fiber includes an outer surface (10, Fig. 3, [0019]), but Nakagawa, in view of Igarashi, fails to expressly teach wherein a maximum distance between the outer surface of the optical fiber and the inner surface of the illumination chamber is 0.1 mm.
However, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nakagawa, in view of Igarashi, so that a maximum distance between the outer surface of the optical fiber and the inner surface of the illumination chamber is 0.1 mm, since a change in size of a component or device is generally recognized as being within the level of ordinary skill in the art MPEP2144.04(IV)(A), and because Applicant has not disclosed that such distance provides an advantage, is used for a particular purpose, or solves a problem.
Regarding claim 16, Nakagawa, in view of Igarashi, teaches a method of illuminating with the insertion apparatus according to claim 1,and Nakagawa further discloses the method comprising: flowing the liquid through the first conduit and through the second opening into the illumination chamber; filling the illumination chamber to a level with the liquid; and radiating the illumination light to an outside of the insertion portion, wherein the level is sufficient to optically couple the distal end of the optical fiber to an illumination window of the illumination lens (The examiner notes that the liquid limitation is conditional (see claim 1)).
Regarding claim 19, Nakagawa discloses a medical kit, comprising: an insertion apparatus (9, Fig. 4, [0057]) including an insertion portion configured for insertion into a subject (60, Fig. 4, [0059]); and a liquid (12, Fig. 4, [0019] -[0036]), wherein the insertion portion includes: a distal end portion (distal end of 60), a first conduit having a first opening (51), an illumination chamber (1x, Fig. 3, [0052]), an optical fiber configured to guide and radiate an illumination light (10, Fig. 3, [0019]), wherein a distal end of the optical fiber is located inside of the illumination chamber (Fig. 3), and an illumination window provided distally relative to the distal end of the optical fiber, wherein the illumination window is configured to radiate the illumination light to an outside of the insertion portion, wherein the illumination window is spaced apart from the distal end of the optical fiber to form a space between the illumination window and the distal end of the optical fiber (Fig. 3 the part inside of 15A), wherein, when the insertion portion is inserted into the subject, the liquid is located in the space (The examiner notes that this is a conditional limitation), and wherein the liquid located in the space when the insertion portion inserted into the subject is either supplied to the subject or suctioned from the subject through the first opening (The examiner notes that this is a conditional limitation).
Nakagawa fails to expressly teach a first conduit having a first opening, wherein the first opening is provided at the distal end portion and the first conduit is in fluid communication with an inside of the subject via the first opening
However, Igarashi teaches of an analogous insertion apparatus (100) wherein the first opening is provided at the distal end portion and the first conduit is in fluid communication with an inside of the subject via the first opening (111).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nakagawa to utilize a first opening, as taught by Igarashi. It would have been advantageous to make the combination for the purpose of inserting a treatment tool ([0227] of Igarashi).
Regarding claim 23, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 1, wherein the liquid located in the space when the insertion apparatus is in use is either supplied to the outside of the insertion portion or suctioned from the outside of the insertion portion through the first opening (The examiner notes that this is a conditional limitation).
Regarding claim 24, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 1, wherein the liquid located in the space when the insertion apparatus is inserted into the subject is a fluid from a region of the subject (The examiner notes that this is a conditional limitation).
Regarding claim 25, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 24, and Nakagawa further discloses wherein the fluid is continuously introduced into the space (12, Fig. 3, [0019]-[0036]).
Regarding claim 26, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 1, and Nakagawa further discloses wherein the optical fiber is a non-hollow optical fiber (10).
Regarding claim 27, Nakagawa, in view of Igarashi, teaches the medical kit according to claim 19, and Nakagawa further discloses wherein the optical fiber is a non- hollow optical fiber (10).
Regarding claim 28, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 22, and Nakagawa further discloses wherein the optical fiber is a non-hollow optical fiber (10).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakagawa and Igarashi, and further in view of EP-3714759-A1 to Schöler and U.S. Publication No. 2022/0107492 to Baumann et al. (hereinafter “Baumann”).
Regarding claim 3, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 1, wherein the illumination lens includes an illumination window extending from a distal end surface of the insertion portion to a distal end surface of the illumination chamber (30A3, Fig. 3, [0049]).
Nakagawa, in view of Igarashi, fails to expressly teach wherein the liquid has a refractive index of 1.33 and wherein the illumination window has a refractive index of 1.63.
However, Schöler further teaches of an insertion apparatus (Schöler: Fig. 1A), wherein the liquid has a refractive index of 1.33 (Schöler: [0237]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nakagawa, in view of Igarashi, so that the liquid has a refractive index of 1.33, as taught by Schöler. It would have been advantageous to make the combination for the purpose of providing refraction ([0237] of Schöler).
Nakagawa, in view of Igarashi, and Scholer, fails to expressly teach wherein the illumination window has a refractive index of 1.63.
However, Baumann teaches of an insertion apparatus (Baumann: Fig. 1) wherein the illumination window has a refractive index of 1.63 (Baumann: [0026])
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nakagawa, in view of Igarashi and Schöler, so that the illumination window has a refractive index of 1.63, as taught by Baumann. It would have been advantageous to make the combination for the purpose of providing better brightness and depth of field ([0026] of Baumann).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP6599996B2 to Nakagawa and Igarashi, and further in view of U.S. Publication No. 2009/0054728 to Trusty.
Regarding claim 5, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 4.
Nakagawa, in view of Igarashi, fails to expressly teach wherein the insertion portion further includes: a discharge conduit having a discharge opening, wherein the discharge conduit is in fluid communication with the outside of the insertion portion via the discharge opening, and wherein the first conduit has a first inner diameter, the discharge conduit has a second inner diameter, and the second inner diameter is smaller than the first inner diameter.
However, Trusty teaches of an insertion apparatus (Trusty: Fig. 1) wherein the insertion portion further includes: a discharge conduit having a discharge opening (Trusty: [0034]), wherein the discharge conduit is in fluid communication with the outside of the insertion portion via the discharge opening (Trusty: [0034]), and wherein the first conduit has a first inner diameter, the discharge conduit has a second inner diameter, and the second inner diameter is smaller than the first inner diameter (Trusty: [0034]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device Nakagawa, in view of Igarashi, to utilize a discharge conduit in the manner taught by Trusty. It would have been advantageous to make the combination for the purpose of providing suction to an area within the body ([0034] of Trusty).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP6599996B2 to Nakagawa, in view of Igarashi, and further in view of U.S. Publication No. 2006/0293564 to Nishiie et al. (hereinafter “Nishiie”).
Regarding claim 6, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 4.
Nakagawa, in view of Igarashi, fails to expressly teach wherein a filter is located in the second opening.
However, Nishiie teaches of an insertion apparatus (Nishiie: Fig. 1) wherein a filter is located in the second opening (Nishiie: 48, Fig. 2, [0053]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nakagawa, in view of Igarashi, to utilize a filter in the manner taught by Nishiie. It would have been advantageous to make the combination for the purpose of preventing at least one of intrusion of dust into the interior of the endoscope ([0012] of Nishiie).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP6599996B2 to Nakagawa and Igarashi, and further in view of U.S. Publication No. 2016/0030707 to Dillon.
Regarding claim 7, Nakagawa, in view of Igarashi, teaches the insertion apparatus according to claim 5, but Nakagawa, in view of Igarashi, fails to expressly wherein the first conduit is configured for insertion of a treatment instrument.
However, Dillon further teaches wherein the first conduit is configured for insertion of a treatment instrument (Dillon: [0032]-[0033]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nakagawa, in view of Igarashi, so that the first conduit is configured for insertion of a treatment instrument. It would have been advantageous to make the combination for the purpose of providing the aspiration or suction.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP6599996B2 to Nakagawa in view of EP3076852B1 to Salman et al. (hereinafter “Salman”).
Regarding claim 22, Nakagawa discloses an insertion apparatus comprising: an insertion portion (60, Fig. 4, [0059]) including: a first conduit having a first opening (51, Fig. 4, [0017]), wherein the first conduit is in fluid communication with an outside of the insertion portion via the first opening (Fig. 4), an illumination chamber having a second opening (1x, Fig. 3, [0052]), wherein the illumination chamber is configured to fluidly communicate with a peripheral part of the first conduit via the second opening (15A, Fig. 3, [0044]), an optical fiber configured to guide and radiate an illumination light (10, Fig. 3, [0019]), wherein a distal end of the optical fiber is located inside of the illumination chamber (Fig. 3), and an illumination lens provided distally relative to the distal end of the optical fiber (30A3, Fig. 3, [0049]), wherein the illumination lens is configured to radiate the illumination light to the outside of the insertion portion ([0049]), wherein the illumination lens includes an illumination window (30A3, Fig. 3, [0049]), wherein the illumination window is spaced apart from the distal end of the optical fiber to form a space between the illumination window and the distal end of the optical fiber (Fig. 3 the part inside of 15A), wherein, when the insertion apparatus is in use, a liquid is located in the space (the examiner notes that this is a conditional limitation), wherein the first conduit is configured to suction a fluid through the first opening and toward a proximal end of the first conduit (the examiner notes that this is a conditional limitation).
Nakagawa fails to expressly teach wherein the peripheral part of the first conduit is configured to allow a portion of a fluid drawn by suction via the first opening to flow toward the illumination chamber via the second opening.
However, Salman teaches of an analogous insertion apparatus (100) wherein the peripheral part of the first conduit is configured to allow a portion of a fluid drawn by suction via the first opening to flow toward the illumination chamber via the second opening ([0068]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nakagawa to utilize a suction, as taught by Salman. It would have been advantageous to make the combination for the purpose of applying suction ([0068]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTEN A. SHARPLESS whose telephone number is (571)272-2387. The examiner can normally be reached Monday-Tuesday 6:00 AM - 2:00 PM, and Friday 6:00 AM - 10:00 AM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.A.S./Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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