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 without traverse of Species B, Sub-Species A of Group I, Sub-Species B of Group II, readable on claims 1-20 in the reply filed on 8/18/2026 is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the claimed subject matter of “a second channel tube through which the outer sheath is inserted, wherein the second channel tube includes a second lumen through which the treatment manipulator is inserted, and the inner diameter of the lumen is 3 to 5 times the inner diameter of the second lumen” in Lines 1-5 of Claim 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 11 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 11 recites the limitation “a second channel tube through which the outer sheath is inserted, wherein the second channel tube includes a second lumen through which the treatment manipulator is inserted, and the inner diameter of the lumen is 3 to 5 times the inner diameter of the second lumen” in Lines 1-5, wherein it’s unclear how the second channel tube enabling insertion of the outer sheath therethrough as well as providing a second lumen through which the treatment manipulator is inserted since the second channel tube, denoted by numeral 172, in Fig. 52 only comprises a single lumen and does not appear to allow insertion of the treatment manipulator or the outer sheath therethrough. Therefore, it’s unclear the structure of the device due to the conflicting structure between the claim language and what’s recited in the specification regarding the second channel tube. Appropriate correction is required.
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.
Claims 1-3, 5-6, 8, 12-13, 15-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Major et al. (US Patent Application Publication No. 2023/0128263, hereinafter Major).
In regard to claim 1, Major discloses a medical manipulator (Fig. 1, Par. 34), comprising:
an outer sheath (210,212, Fig. 5);
a bendable bending portion (102) arranged in the outer sheath (Fig. 1); and
a bending wire (180,182,184,186) for bending the bending portion (Fig. 2A, Par. 41),
wherein the bending portion includes a plurality of ring members (any two adjacent links (132)) through which the bending wire is inserted (Fig. 2A),
wherein the plurality of ring members are arranged at a distance along a longitudinal direction of the outer sheath (Fig. 2A).
In regard to claim 12, Major teaches medical manipulator system (600, Fig. 17), comprising:
a medical manipulator including an outer sheath (210,212, Fig. 5), a bendable bending portion (102) disposed in the outer sheath (Fig. 1), a bending wire (180,182,184,186) that bends the bending portion (Fig. 2A, Par. 41);
a drive unit (612) that drives the medical manipulator (Par. 65); and
a control device (606) that controls the drive unit (Par. 602), wherein the bending portion includes a plurality of ring members (any two adjacent links (132)) through which the bending wire is inserted (Fig. 2A), and
the plurality of ring members are disposed at a distance along the longitudinal direction of the outer sheath (Fig. 2A).
In regard to claims 2 and 13, Major teaches further comprising a spring (140) formed in a spiral shape along the longitudinal direction (Fig. 2A),
wherein the outer sheath is arranged outside the spring (Fig. 5).
In regard to claims 3 and 14, Major teaches wherein each of the plurality of ring members has a slit (gaps between arcuate members (150,152,154,156) of the links (132), Fig. 2a) into which the spring is fitted (Fig. 2a),
wherein each of the plurality of ring members is attached to the spring by fitting the spring into the slit (Fig. 2a).
In regard to claims 5 and 16, Major teaches wherein the bending wire is composed of at least three wires including a first bending wire, a second bending wire, and a third bending wire (via four bending wires, Fig. 2a).
In regard to claim 6, Major teaches wherein the first bending wire, the second bending wire, and the third bending wire are evenly arranged along a circumferential direction relative to the longitudinal direction (Fig. 2a).
In regard to claims 8 and 18, Major teaches wherein the outer sheath includes a braided tube (210) in which wires are woven into a braid shape (Fig. 5), and
a coating (212) attached to at least one of inner and outer circumferential sides of the braided tube (Fig. 5).
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.
Claims 4, 7, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Major et al. (US Patent Application Publication No. 2023/0128263, hereinafter Major) in view of Kakehashi (US Patent Application Publication No. 2016/0262595, hereinafter Kakehashi).
In regard to claims 4 and 15, Major does not expressly teach wherein the spring is formed in a flat wire shape.
Kakahashi teaches an analogous endoscope comprising a coil sheath (20) within the insertion section. Kakahashi teaches a plurality of cross-sectional shapes can be used to construct the coil sheath, such as generally circular shapes in Figs. 3-4 and Figs. 5-6, as well as flat wire shapes in Figs. 9-10. Kakahashi teaches that by providing the coil sheath with a flat inner and outer surfaces in Figs. 9-10 allows the the coil sheath to be formed of a smaller diameter.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the spring of Major to be formed of a flat wire (20) as taught by Kakahashi as a matter of design choice enabling the spring to be smaller in diameter and therefore reducing the size of the insertion portion (Par. 99).
In regard to claims 7 and 17, Major does not expressly teach wherein the bending wire is inserted into the coil sheath on a proximal side of the ring member arranged at the most proximal end among the plurality of ring members.
Kakahashi teaches an analogous endoscope comprising a plurality of coil sheaths (20) within a flexible tube (2k) of an insertion section, wherein a distal end of the coil sheath is mounted adjacent a proximal end of the bending section of the insertion section. The coil sheaths are configured to surround pull wires extended therethrough and largely prevent the flexible tube (2k) from bending when the pull wires are actuated (Par. 62).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the insertion section of Major with the coil sheath (20) as taught by Kakahashi as a matter of design choice providing a lumen through which the pull wires are inserted as well as preventing the flexible tube of the insertion section from bending during actuation of the pull wires to bend the bending portion of the insertion section.
Claims 9, 10, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Major et al. (US Patent Application Publication No. 2023/0128263, hereinafter Major) in view of Ishikawa et al. (US Patent Application Publication No. 2003/0229296, hereinafter Ishikawa).
In regard to claims 9 and 10, Major does not expressly teach further comprising a channel tube through which the outer sheath is inserted, wherein the channel tube includes a braided tube in which wires are woven into a braid shape, and a coating attached to at least one of the inner and outer circumferential sides of the braided tube, wherein the channel tube includes a lumen through which a treatment manipulator is inserted, and an inner diameter of the lumen is at least half of an outer diameter of the outer sheath.
Ishikawa teaches an analogous endoscope system comprising a guide tube (1) for aiding insertion of an endoscope (100) within a stomach of a patient. The guide tube comprising a shaft section (2) having a lumen for insertion of the endoscope (100, i.e. outer sheath) therethrough. The proximal section (19a) of the guide tube has a reinforcing layer that can be formed of a braided structure surrounded by resin (Figs. 12-13, Par. 59). The lumen can additionally be used to deliver other instruments directly through the lumen or through a lumen of the endoscope disposed within the guide tube.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope of Major with the guide tube of Ishikawa thereby providing a lumen through which the endoscope can be stably inserted within a stomach of a patient. There being no unexpected results in using the endoscope of Major with the guide tube of Ishikawa.
In regard to claim 19, Major teaches of passing standard sized instruments (i.e. treatment manipulator/tool) through the inner diameter (D4) of the endoscope, but does not expressly teach wherein the medical manipulator further includes a channel tube through which the outer sheath is inserted, the treatment manipulator or treatment tool is inserted into the channel tube, and the channel tube includes a braided tube in which wires are woven into a braid shape, and a coating attached to at least one of the inner and outer circumferential sides of the braided tube.
Ishikawa teaches an analogous endoscope system comprising a guide tube (1) for aiding insertion of an endoscope (100) within a stomach of a patient. The guide tube comprising a shaft section (2) having a lumen for insertion of the endoscope (100, i.e. outer sheath) therethrough. The proximal section (19a) of the guide tube has a reinforcing layer that can be formed of a braided structure surrounded by resin (Figs. 12-13, Par. 59). The lumen can additionally be used to deliver other instruments directly through the lumen or through a lumen of the endoscope disposed within the guide tube.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope of Major with the guide tube of Ishikawa thereby providing a lumen through which the endoscope can be stably inserted within a stomach of a patient. There being no unexpected results in using the endoscope of Major with the guide tube of Ishikawa.
In regard to claim 20, Ishikawa teaches wherein the medical manipulator includes a notch on a distal end surface into which a portion of the treatment manipulator or treatment tool fits (Fig. 11 illustrates a tapered notch at a distal end of the guide tube through which a treatment manipulator/tool can extend through).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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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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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 September 17, 2026
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