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 .
Election/Restrictions
Applicant’s election of Invention I and Species I corresponding to claims 1-4, 9-10, and 26 in the reply filed on 5/19/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 5-8, 11-25, and 27-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II and nonelected Species II-VIII, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/19/2026.
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 3 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 3 recites the limitation "the balloon" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the balloon” is being interpreted as “the at least one balloon of the first ballon or the second balloon.”
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 1-4 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0154983 A1 to Yamada (“Yamada”).
Regarding claim 1, Yamada discloses an overtube that is long and flexible, the overtube comprising:
an inner tube (first overtube 11; Fig. 1, paragraph 0026) having a first insertion path into which an endoscope insertion part is insertable (the inner diameter of a first channel 16 of the first overtube 11 has a dimension with which the first endoscope 10 can be inserted thereinto with a space in the radial direction; Figs. 1 and 3, paragraph 0026);
an outer tube (second overtube 21; Fig. 2, paragraph 0027) having a second insertion path into which the inner tube is insertable (when the first overtube 11 is inserted into the second channel 26 in the second overtube 21 the slit 27 opens, the inner diameter of the second overtube 21 is increased, and the inner surface of the second overtube 21 contacts the outer surface of the first overtube 11; Figs. 5 and 10, paragraph 0028);
a first balloon provided at a distal end part of the inner tube (the first overtube 11 and the second overtube 21 are respectively equipped with inflatable and deflatable balloons 12 and 22 on the distal end side; Fig. 1, paragraph 0025); and
a second balloon provided at a distal end part of the outer tube (the first overtube 11 and the second overtube 21 are respectively equipped with inflatable and deflatable balloons 12 and 22 on the distal end side; Fig. 2, paragraph 0025).
However, Yamada does not explicitly disclose wherein an effective length of the outer tube is 1200 mm or longer and 1700 mm or shorter, an effective length of the inner tube is 1400 mm or longer and 2000 mm or shorter, in a case in which the endoscope insertion part is inserted into the first insertion path and the inner tube is inserted into the second insertion path, a total maximum protrusion length, which is a sum of a first maximum protrusion length of the endoscope insertion part from a distal end of the inner tube and a second maximum protrusion length of the inner tube from a distal end of the outer tube, is 300 mm or longer and 800 mm or shorter, the first maximum protrusion length is 100 mm or longer and 550 mm or shorter, the second maximum protrusion length is 200 mm or longer and 700 mm or shorter, and a maximum protrusion length ratio, which is a ratio of the first maximum protrusion length to the second maximum protrusion length, is 0.15 or more and 1.0 or less.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the effective length of the outer tube set to 1200 mm or longer and 1700 mm or shorter, the effective length of the inner tube set to 1400 mm or longer and 2000 mm or shorter, the total maximum protrusion length set to 300 mm or longer and 800 mm or shorter, the first maximum protrusion length set to 100 mm or longer and 550 mm or shorter, the second maximum protrusion length set to 200 mm or longer and 700 mm or shorter, and the maximum protrusion ration set to 0.15 or more and 1.0 or less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the overtube would not operate differently with the claimed effective lengths and protrusion lengths. Further, Applicant places no criticality on the ranges claimed, indicating that “it should be noted that the conditions M1 to M6 indicate preferred ranges in the present embodiment, but the values are not necessarily limited to the values in these ranges” in paragraph 0137 of Applicant’s specification.
Regarding claim 2, Yamada teaches the overtube according to claim 1. However, Yamada does not explicitly teach wherein an axial length of at least one balloon of the first balloon or the second balloon is 50 mm or longer. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the axial length of at least one of the balloons be 50 mm or longer since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the balloon would not operate differently with the claimed axial length. Further, Applicant places no criticality on the ranges claimed, indicating that “it is preferable that a length (axial length) P1 of the first ballon 120 in the central axis K direction is 50 mm or longer” in paragraph 0073 of Applicant’s specification.
Regarding claim 3, Yamada teaches the overtube according to claims 1-2. Yamada further teaches wherein the balloon has a bulging part that is expandable and contractable (the first overtube 11 and the second overtube 21 are respectively equipped with inflatable and deflatable balloons 12 and 22 on the distal end side; Fig. 10, paragraph 0025). However, Yamada does not explicitly teach an axial length of the bulging part is 30 mm or longer. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the axial length of the bulging part be 30 mm or longer since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the balloon would not operate differently with the claimed bulging part axial length. Further, Applicant places no criticality on the ranges claimed, indicating that “it is preferable that a length (axial length) Q1 of the bulging part 120c in the central axis K is 30 mm or longer” in paragraph 0073 of Applicant’s specification.
Regarding claim 4, Yamada teaches the overtube according to claim 1. Yamada further teaches an inner tube gripping part provided at a base end part of the inner tube (the first overtube 11 and the second overtube 21 are respectively equipped with … grip units 13 and 23 on the proximal end side; Fig. 1, paragraph 0025); and an outer tube gripping part provided at a base end part of the outer tube (the first overtube 11 and the second overtube 21 are respectively equipped with … grip units 13 and 23 on the proximal end side; Fig. 2, paragraph 0025). However, Yamada does not explicitly teach wherein the inner tube gripping part and the outer tube gripping part each have an axial length of 15 mm or longer and 200 mm or shorter. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the axial length of the inner tube gripping part and the outer tube gripping part be 15 mm or longer and 200 mm or shorter since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the overtube would not operate differently with the claimed axial lengths of the inner tube gripping part and the outer tube gripping part. Further, Applicant places no criticality on the ranges claimed, indicating that “the inner tube gripping part 104 … is preferably formed to have a length (axial length) in the central axis K direction of 15 mm or longer and 200 mm or shorter” in paragraph 0068 of Applicant’s specification.
Regarding claim 26, Yamada teaches the overtube according to claim 1. Yamada further teaches an endoscope system comprising the overtube according to claim 1 (see rejection of claim 1 above) and an endoscope having the endoscope insertion part (first endoscope 10; Fig. 1, paragraph 0024). However, Yamada does not explicitly teach wherein an effective length of the endoscope insertion part is 2000 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the effective length of the endoscope insertion part be 2000 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the endoscope would not operate differently with the claimed effective length. Further, Applicant places no criticality on the ranges claimed, indicating that “the conditions M1 to M6 (as well as N1 to N6) can also be applied to the endoscope insertion part 12 in which the effective length is 1500 mm or longer and 2500 mm or shorter” in paragraph 0138 of Applicant’s specification.
Allowable Subject Matter
Claims 9-10 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 9, Yamada teaches the overtube according to claim 1. Yamada further teaches wherein the inner tube and the outer tube have a lubricant supply part that supply a lubricant (the grip units 13 and 23 respectively having … eater valves 15 and 25; Fig. 1-2, paragraph 0025).
However, Yamada does not explicitly disclose wherein the lubricant supply part has an inner supply port that is open to an inner peripheral surface of the inner tube and an outer supply port that is open to an outer peripheral surface of the inner tube.
U.S. Patent Appl. Publ. No. 2011/0137121 A1 to Itoi teaches wherein the inner tube has a lubricant supply part that supplies a lubricant (the overtube 50 has a lubricant inlet 66, which is connected to a lubricant supply path 68; Fig. 4, paragraph 0068), and the lubricant supply part has an inner supply port that is open to an inner peripheral surface of the inner tube (a plurality of openings 75 are formed at predetermined intervals in the lubricant supply path 68 and the tube body 51 as shown in Fig. 4 to supply the lubricant poured into the lubricant supply path 68 to inside the tube body 51; Fig. 4, paragraph 0068).
However, Itoi does not explicitly teach an outer supply port that is open to an outer peripheral surface of the inner tube.
Additionally, there is no reason, teaching, or suggestion provided with any prior art of record to modify the above overtube to have the above features.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2012/0323074 A1 to Iyama et al. teaches an overtube with a lubricating liquid supply passage which is in communication with the plurality of supply ports as described in the abstract and Fig. 11.
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
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