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
Claims 1-8 are pending.
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.
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.
Claim(s) 1-7, is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueda (EP 2 364 637) in view of Machida (US 20050137457).
Regarding claim 1, Ueda discloses an overtube (overtube 11; FIG. 3, annotated) comprising:
an overtube body (body 61) that has a distal end, a proximal end, and a central axis and in which an endoscope insertion passage is formed between the distal end and the proximal end along the central axis (Inserter/insertion portion 13 of the endoscope system 2 is passed through body 61; FIGS. 1, 3); and
a balloon (balloon 76; FIG.3) that is provided on an outer circumferential surface of the overtube body, and is disposed between a first position (first position ) in a direction of the central axis of the overtube body and a second position (second position) positioned on a proximal end side of the overtube body from the first position (The distance of the positions from the balloon are not defined in the claim. Any two positions on the left and right side of the balloon may be considered as two positions.), wherein the overtube body has a ventilation hole-formed region provided on the proximal end side from the second position (A region where air hole 90, 91 are positioned. Para [0043]), and a ventilation hole (Air holes 90, 91) that allows the outer circumferential surface and the endoscope insertion passage to communicate with each other is provided in the ventilation hole-formed region (Air holes 90, 91 communicate from outside of the over tube body 61 to the passageway where the insertion section of the endoscope 2 is inserted. FIG 3, annotated; para [0043]-[0044], [0055]),
wherein in a case where the over tube body is inserted in a subject body, and a gas on a proximal end side of the balloon is accumulated in a space formed by the outer circumferential surface of the overtube body, the balloon and an inner wall surface of the subject body, the overtube body is configured to discharge the gas from the proximal end side of the overtube body to an outside of the subject body through the ventilation hole via the endoscope insertion passage (Since the air holes 90, 91, communicate from outside the body 61 to the endoscope passageway inside the body 61, the holes help to discharge the gas. In para [0036], the space between the inserter 13 and body 60 has been defined as accommodation hole 70 which is the endoscope insertion passage. The accommodation hole 70 allows for the ventilation of the trapped air in the space formed by the outer circumferential surface of the overtube body, the balloon and an inner wall surface of the subject body), and wherein the endoscope insertion passage is formed by an inner circumferential surface of the overtube body and extends from the proximal end to the distal end opposite to the proximal end (FIG. 3, annotated) and wherein the first position and second position are respectively defined as two positions at which a bulging part of the balloon is in closest proximity to the outer circumferential surface of the overtube body (FIG. 3 annotated).
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Ueda does not expressly disclose the ventilation hole is located in a region within a range of 5 mm or more and 100 mm or less from the second position toward the proximal end side of the overtube body so as to prevent the ventilation hole from being closed during endoscopy.
Machida is directed to an insertion assisting tool for an endoscope (FIG. 1; FIGS. 4, 5, annotated; an overtube 50) and teaches a ventilation hole (air release hole 80; FIG. 4) wherein
a ventilation hole is located in a region within a range of 5 mm or more and 100 mm or less from the second position (Balloon 60 is about 50 mm; para [0032]; In view of para [0035], air hole 80 may be formed at a plurality of locations- equidistantly around the tube body 51 and at equal spaces in the axial direction, para [0035]. Considering the size of the balloon, 50 mm, see annotated FIG. 4; FIG. 6F, the ventilation hole can be considered anywhere between 5 mm -100 mm from the second position. Since the balloon is disposed between the first position and second position, and these positions are not defined in the claim, any two positions that include the balloon can be considered as these two positions. Thus, the second position can be chosen as needed so that the ventilation hole is located within the required distance from the second position meeting the claim requirement. The examiner notes that - the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977), MPEP 2125.) toward the proximal end side of the overtube body so as to prevent the ventilation hole being closed during endoscopy.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ueda to position the ventilation holes in accordance with the teaching of Machida so that the air holes remain away from the balloon so that air flow through the holes are not affected during expansion of the balloons. Further, keeping the air holes a few centimeters away from the balloon would avoid damaging the balloon during the manufacturing of the overtube because having the hole formed too close to the balloon would potentially damage the balloon surface during manufacturing.
Regarding claim 2, Ueda as modified teaches wherein the ventilation hole-formed region (Machida: Air release hole 80) is in a region within a range of 15 mm or more and 40 mm or less from the second position toward the proximal end side of the overtube body (Machida: As discussed above, the exact location/coordinate of the second position is not defined. Balloon 60 is about 50 mm; para [0032]; In view of para [0035], Air hole 80 may be formed at a plurality of locations equidistantly around the tube body 51 and at equal spaces in the axial direction, para [0035]. Considering the size of the balloon, 50 mm, see annotated FIGS. 4, 6, the ventilation hole can be anywhere between 15 mm-40 mm, i.e., between 1.5 cm - 4 cm from the position of the balloon 6c. Since the air release hole 80 has a function of releasing air stored between the tube body and intestinal canal, air release hole 80 needs to be placed outside balloon 6c. The examiner notes that - the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977), MPEP 2125.).
Regarding claim 3, Ueda discloses wherein a plurality of the ventilation holes are provided in the ventilation hole-formed region (FIG. 3; Air holes 90, 91).
Regarding claim 4, Ueda discloses wherein the overtube body has a liquid supply port (an air/water feed button 21; FIG. 3) through which a liquid is supplied to the endoscope insertion passage, the ventilation hole is located at a position clockwise to the liquid supply port about the central axis (The ventilation hole is located at a position clockwise to the liquid supply port about the central axis. FIG. 3), and an included angle between the ventilation hole and the liquid supply port with respect to the central axis is less than 180 degrees (Angle between the ventilation hole and the liquid supply port with respect to the central axis is less than 180 degrees. FIG. 3; The formation of this angle is not exactly defined. Any point in the central axis could be used to define a desired angle.).
Regarding claim 5, Ueda as modified teaches wherein the included angle is in a range of 45 degrees or more and 135 degrees or less (A point could be chosen in the central axis to form an angle in the range of 45 degrees or more and 135 degrees or less. See annotated FIG. 3 below).
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Regarding claim 6, Ueda discloses wherein a region of the overtube body on the proximal end side from the ventilation hole-formed region is a ventilation hole-nonformed region (There is a ventilation hole-nonformed region on the proximal end side of the ventilation hole-formed region.).
Regarding claim 7, Ueda discloses wherein a gripping part (Proximal portion of the endoscope; FIG. 1) is provided on the proximal end side of the overtube body, and the gripping part has a discharge hole (Hole provided by the tube 73, for injecting lubricant for the conductor 70. The connector 72 is connected to a small-diameter tube 73, and the distal end of the tube 73 is connected to the proximal end of the insertion conduit 70. FIG. 3) that communicates with an outer circumferential surface of the gripping part and the endoscope insertion passage.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueda (EP 2 364 637) in view of Machida (US 20050137457) and further in view of Fischer (WO 2020036497).
Regarding claim 8, Ueda does not expressly disclose wherein a ventilation film that selectively allows a gas to pass therethrough without allowing a liquid to pass therethrough is provided in the ventilation hole.
Fischer is directed to surgical cannula for providing insufflation gases to a surgical cavity (abstract) and teaches wherein a ventilation film that selectively allows the gas to pass therethrough (filter to allow a gas to pass through; Para [0163]; FIGS. 23A-C; selectively allow gases to pass through; para [0171]) without allowing a liquid to pass therethrough is provided in the ventilation hole.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Ueda’s air holes to include a filter in the ventilation hole in accordance with the teaching of Fischer so that the gas could be vented out and bodily fluid could be maintained inside the body.
Response to Arguments
Applicant’s arguments, submitted on 06/4/2026 has been fully considered but the arguments are not persuasive. See rejection set forth above.
Claim 1
The ventilation holes 90, 91 are through-holes, FIG. 3, annotated below, and are configured to discharge the gas from the proximal end side of the over tube body to outside the body by allowing the trapped gas in the proximal end side of the balloon to accumulate near the distal side of the balloon through the endoscope insertion passage 70, from the distal end side, the gas is suctioned out to the outside of the body (Para [0055], [0056]). Thus, the holes 90, 91 are configured for performing what the claim is calling for – i.e., allowing the outer circumferential surface and the endoscope insertion passage to communicate with each other by way of having through holes, and configured to discharge the gas from the proximal end side of the overtube body to an outside of the subject body through the ventilation hole via the endoscope insertion passage 70.
Accordingly, applicants’ arguments are not persuasive.
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Thus, the examiner respectfully disagrees with the applicants’ arguments.
Accordingly, claim 1 is rejected.
Conclusion
THIS ACTION IS MADE FINAL. 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 SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 7/23/26
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