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 amendment filed on 12/8/2025 has been entered. Claims 1-14 remain pending in the application. Applicant’s amendments to the Drawings, Specification, and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 8/8/2025. The claim interpretations invoked under 35 USC § 112(f) set forth in the Non-Final Office Action mailed 8/8/2025 have been withdrawn due to Applicant’s amendments.
Response to Arguments
Applicant's arguments, see pages 11-13, filed 12/8/2025 have been fully considered but they are not persuasive.
Applicant has amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 103 rejections identified in the non-final dated 8/8/2025 moot, and require a new ground of rejection. Therefore, the 103 rejections previously identified in the non-final action dated 8/8/2025 have been withdrawn.
However, upon further search and consideration, a new ground of rejection is made below. The new rejection under 35 USC § 103 is made over Fan in view of Kawashima. The Applicant’s arguments are on the basis that one can not reasonably interpret the combination of Fan and Kawashima in any way that corresponds to the configuration specified in the newly amended claim 1. Specifically, the configuration of the insertion pipe line being separate and distinct from the introduction pipe line, the proximal end of the insertion pipe line facing the introduction pipe line and the suction pipe line, and the opening facing the introduction pipe line and the suction pipe line. Examiner respectfully disagrees. Fan discloses the configuration of the insertion pipe line being separate and distinct from the introduction pipe line (paragraph 0047) and the proximal end of the insertion pipe line facing the introduction pipe line and the suction pipe line (Fig. 3). Fan, as modified by Kawashima, teaches the opening facing the introduction pipe line and the suction pipe line (col. 4, l. 13-18). Please see section 35 USC § 103 below for further explanation.
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 3, 6, and 9 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 "a side of a suction pipe line" in line 3. Claim 1 introduces a suction pipe line. It is unclear if the applicant is referring to the suction pipe line presented in claim 1 or another additional suction pipe line. For the purposes of examination, “a side of a suction pipe line” is being interpreted as “a side of the suction pipe line.”
Claims 6 and 9 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.
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 1-3 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2015/0374214 A1 to Fan (“Fan”) in view of U.S. Patent No. 4,732,139 to Kawashima et al. (“Kawashima”).
Regarding claim 1, Fan discloses an endoscope (endoscope main body part 10; Fig. 1, paragraph 0035) comprising:
an introduction pipe line (insertion tube 23; Fig. 3, paragraph 0041) into which a treatment tool is introduced (a treatment tool such as forceps, a snare, or a brush is inserted in the insertion tube 23; Fig. 3, paragraph 0049);
an insertion pipe line (pipe 33; Fig. 3, paragraph 0039) into which the treatment tool is inserted after passing through the introduction pipe line (the inserted forceps or the like passes through the tube path 20 in the tube part 21 and is inserted into the treatment tool insertion tube via the tapered part 34 and the pipe 33 formed on the support part 28; Fig. 3, paragraph 0050), the insertion pipe line being separate and distinct from the introduction pipe line (the attachment and removal part 25 is attachably and detachably formed with respect to the support part 28; Fig. 3, paragraph 0047);
a suction pipe line (a pipe 32 is joined, is connected to a suction valve with the pipe tube 32 via a tube made of synthetic resin; Fig. 3, paragraph 0039); and
a brancher (the support part 28 is formed to be bifurcated; Fig. 3, paragraph 0038) configured to provide communication between the insertion pipe line, the introduction pipe line, and the suction pipe line (paragraphs 0039 and 0049-0050),
wherein a proximal end portion of the insertion pipe line is inserted into the brancher towards the introduction pipe line and the suction pipe line (the pipe 33 formed on the support part 28 to which the tip part of the tube part 21 communicates; Fig. 3, paragraph 0050) such that a proximal end of the insertion pipe line faces the introduction pipe line and the suction pipe line (the proximal end of pipe 33 faces towards the insertion tube 23 and the pipe 32; Fig. 3), and
the proximal end portion of the insertion pipe line integrally includes a first part and a second part, the second part being disposed closer to the proximal end of the insertion pipe line than the first part (the proximal end portion of tube 33 includes a first part and a second part as seen in annotated Fig. 3 below; Fig. 3).
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However, Fan does not explicitly teach an opening facing a side of the introduction pipe line and the suction pipe line is formed in an outer peripheral surface of the second part.
Kawashima teaches an opening facing a side of the introduction pipe line is formed in an outer peripheral surface of a tube (the distal end portion of pipe 30a is cut off excluding a given portion, thus forming tongue portion 30c. Tongue portion 30c is located to face inlet opening 33c, and one end of outlet pipe 40 is inserted in insertion hole 26c through inlet opening 33c and abuts against tongue portion 30c; Fig. 5-6, col. 4, l. 13-18). Kawashima teaches that the tongue portion helps to prevent damage to the inner surface of the branching member when the introduction tube is inserted (col. 4, l. 19-24).
Kawashima is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a tool insertion part in the operation section. It would have been prima facie obvious to one of ordinary skill in the art before the effective date of the claimed invention to have modified the second part of the insertion pipe line of Fan to incorporate the teachings of Kawashima by cutting an opening into the second part to form a tongue facing a side of the introduction pipe line and the suction pipe line. Doing so would help to prevent damage to the inner surface of the branching member when the introduction tube is inserted, as recognized by Kawashima.
Regarding claim 2, Fan, as previously modified by Kawashima, teaches the endoscope according to claim 1. Fan further discloses wherein an inner peripheral surface of the second part intersects an extension line of an axis of the introduction pipe line (extension line of an axis of the introduction pipe line is represented by a dotted line as seen in annotated Fig. 3 below; Fig. 3).
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Regarding claim 3, Fan, as previously modified by Kawashima, teaches the endoscope according to claims 1-2. Fan further discloses wherein a position of an end edge of the second part in an axial direction of the insertion pipe line is located on a side of the suction pipe line with respect to an intersection position between the extension line of the introduction pipe line and the inner peripheral surface of the second part (as seen in annotated Fig. 3 below, the end edge of the insertion pipe line is proximal to the intersection position between the extension line of the introduction pipe line and the inner peripheral surface of the second part; Fig 3).
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Regarding claim 10, Fan, as previously modified by Kawashima, teaches the endoscope according to claim 1. Fan further discloses wherein the brancher includes a body part that includes the introduction pipe line (the insertion part 26 in a tube path shape arranged in the tube part 21 configuring the endoscope main body part 10 and through which the insertion tube 23 is inserted and removed; Fig. 3, paragraph 0037) and an opening through which the insertion pipe line is inserted (the insertion part 26 has a lower end part where a tapered part 34 in a truncated cone shape is formed, and communicated to the pipe 33 via the tapered part 34; Fig. 3, paragraph 0040), and a connector configured to connect the body part and the suction pipe line to each other (the tube path part 27 and the insertion part 26 are coupled together via a connecting part 30; Fig. 3, paragraph 0038).
Regarding claim 11, Fan, as previously modified by Kawashima, teaches the endoscope according to claims 1 and 10. Fan further discloses wherein the connector includes a connection portion to which the suction pipe line is connected (portion of connecting part 30 connected to the tube path part 27; Fig. 3) and a guide configured to guide a movement of the treatment tool inserted into the introduction pipe line (portion of connecting part 30 connected to the insertion part 26; Fig. 3).
Regarding claim 12, Fan, as previously modified by Kawashima, teaches the endoscope according to claims 1 and 10-11. Fan further discloses wherein the guide has a guide surface along the introduction pipe line, and an edge of the guide surface is rounded (the surface of the portion of connecting part 30 connected to the insertion part; Fig. 3). The edge of the surface of the portion of the connection part 30 that makes contact with the insertion part is rounded since the insertion part is cylindrical (paragraph 0040).
Claims 4-9 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Kawashima as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2024/0057851 A1 to Busch et al. (“Busch”).
Regarding claim 4, Fan, as previously modified by Kawashima, teaches the endoscope according to claim 1. However, Fan, as modified by Kawashima, does not explicitly teach wherein the brancher includes a contact surface that comes into contact with an edge surface of the first part on a second part side of the first part.
Busch teaches wherein the brancher includes a contact surface that comes into contact with an edge surface of the first part on a second part side of the first part (The outlet adapter 120 is in the form of a sleeve having a coaxial ring-shaped disc 140 at its radial outer surface distant to the outlet opening 114. The disc 140 … is formed to abut against the attached top part 104; Fig. 9, surface of #100 that comes into contact with #140, paragraph 0076). Busch teaches that the special structural configuration of the outlet adapter helps to provide a specific coupling to the endoscope handle and is easily moulded without any rotational core mould pieces (paragraph 0073).
Busch is considered analogous to the claimed invention because it is in the same field of endoscopes with Y-shaped tube connector. 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 brancher of Fan, as modified by Kawashima, to incorporate the teachings of Busch by adding a disc to the outer surface of the first part that makes contact with the brancher. Doing so would help to provide a specific coupling to the endoscope handle and be easily moulded without any rotational core mould pieces, as recognized by Busch.
Regarding claim 5, Fan, as previously modified by Kawashima, teaches the endoscope according to claims 1- 2. However, Fan, as modified by Kawashima, does not explicitly teach wherein the brancher includes a contact surface that comes into contact with an edge surface of the first part on a second part side of the first part.
Busch teaches wherein the brancher includes a contact surface that comes into contact with an edge surface of the first part on a second part side of the first part (The outlet adapter 120 is in the form of a sleeve having a coaxial ring-shaped disc 140 at its radial outer surface distant to the outlet opening 114. The disc 140 … is formed to abut against the attached top part 104; Fig. 9, surface of #100 that comes into contact with #140, paragraph 0076). Busch teaches that the special structural configuration of the outlet adapter helps to provide a specific coupling to the endoscope handle and is easily moulded without any rotational core mould pieces (paragraph 0073).
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 brancher of Fan, as modified by Kawashima, to incorporate the teachings of Busch by adding a disc to the outer surface of the first part that makes contact with the brancher. Doing so would help to provide a specific coupling to the endoscope handle and be easily moulded without any rotational core mould pieces, as recognized by Busch.
Regarding claim 6, Fan, as previously modified by Kawashima, teaches the endoscope according to claims 1-3. However, Fan, as modified by Kawashima, does not explicitly teach wherein the brancher includes a contact surface that comes into contact with an edge surface of the first part on a second part side of the first part.
Busch teaches wherein the brancher includes a contact surface that comes into contact with an edge surface of the first part on a second part side of the first part (The outlet adapter 120 is in the form of a sleeve having a coaxial ring-shaped disc 140 at its radial outer surface distant to the outlet opening 114. The disc 140 … is formed to abut against the attached top part 104; Fig. 9, surface of #100 that comes into contact with #140, paragraph 0076). Busch teaches that the special structural configuration of the outlet adapter helps to provide a specific coupling to the endoscope handle and is easily moulded without any rotational core mould pieces (paragraph 0073).
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 brancher of Fan, as modified by Kawashima, to incorporate the teachings of Busch by adding a disc to the outer surface of the first part that makes contact with the brancher. Doing so would help to provide a specific coupling to the endoscope handle and be easily moulded without any rotational core mould pieces, as recognized by Busch.
Regarding claim 7, Fan, as previously modified by Kawashima and Busch, teaches the endoscope according to claims 1 and 4. Busch further teaches wherein the contact surface is a surface perpendicular to an axial direction of the insertion pipe line (the disc 140 is formed perpendicular to the longitudinal axis L1 and L2 and is formed to abut against the attached top part 104; Fig. 9, surface of #100 that comes into contact with #140, paragraph 0076).
Regarding claim 8, Fan, as previously modified by Kawashima and Busch, teaches the endoscope according to claims 1-2 and 5. Busch further teaches wherein the contact surface is a surface perpendicular to an axial direction of the insertion pipe line (the disc 140 is formed perpendicular to the longitudinal axis L1 and L2 and is formed to abut against the attached top part 104; Fig. 9, surface of #100 that comes into contact with #140, paragraph 0076).
Regarding claim 9, Fan, as previously modified by Kawashima and Busch, teaches the endoscope according to claims 1-3 and 6. Busch further teaches wherein the contact surface is a surface perpendicular to the axial direction of the insertion pipe line (the disc 140 is formed perpendicular to the longitudinal axis L1 and L2 and is formed to abut against the attached top part 104; Fig. 9, surface of #100 that comes into contact with #140, paragraph 0076).
Regarding claim 13, Fan, as previously modified by Kawashima, teaches the endoscope according to claim 1. However, Fan, as modified by Kawashima, does not explicitly teach wherein the brancher and the introduction pipe line are integrally formed.
Busch teaches wherein the brancher and the introduction pipe line are integrally formed (in a third step S3, the second part 104 is attached to the first part 102 thus assembling the connector 100, and both parts 102, 104 are glued together along the petition line, thereby permanently fixing the bottom part 102 to the top part 104; Fig. 3 and 12, #100, paragraph 0080). Busch teaches that gluing the pieces together helps to avoid accidental disassembly (paragraph 0023).
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 brancher of Fan, as modified by Kawashima, to incorporate the teachings of Busch by gluing the components of the brancher together. Doing so would help to avoid accidental disassembly, as recognized by Busch.
Regarding claim 14, Fan, as previously modified by Kawashima, teaches the endoscope according to claim 1. However, Fan, as modified by Kawashima, does not explicitly teach wherein the brancher is made of a resin.
Busch teaches wherein the brancher is made of a resin (both the bottom part 102 and the top part 104 are made of moldable plastic, preferably thermoplastic and/or thermosetting polymers, that are simple and cost effective moldable. Further preferred, the material of the connector 100 is a biocompatible material; Fig. 3, #100, paragraph 0069). Busch teaches that constructing the connector of resin helps to reduce tooling cost for the manufacturing of the connector (paragraph 0068-0069).
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 brancher of Fan, as modified by Kawashima, to incorporate the teachings of Busch by constructing it of resin. Doing so would help to reduce tooling cost for the manufacturing of the connector, as recognized by Busch.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795