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 a in the reply filed on 06/05/2026 is acknowledged.
Status of Claims
Claims 1-18 is pending and currently under consideration for patentability under 37 CFR 1.104
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copies have been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/18/2024 and 05/13/2025 has been considered by the examiner.
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 side portion being a straight line (claim 6) 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 § 102
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) 1, 2, 4, 5, 7, 8, 11, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takahashi (U.S. 2021/0145258).
With respect to claim 1, Takahashi teaches an insertion assisting tool comprising:
a tube body (70) that includes an insertion pipe line (71) into which an endoscope insertion part is insertable and that is inserted into a body cavity; and
a tubular gripping part (76) that is connected to a proximal end side of the tube body and that has an insertion port which communicates with the insertion pipe line (FIG. 3),
wherein in cross-sectional view that is viewed from a direction orthogonal to an axial direction of the gripping part, at least a part of an outer peripheral surface of the gripping part has a shape formed by standardization (79, FIG. 4).
With respect to claim 2, Takahashi teaches in the outer peripheral surface of the gripping part, at least two surfaces facing each other in the direction orthogonal to the axial direction have the standardized shape (79, FIG. 4).
With respect to claim 4, Takahashi teaches the outer peripheral surface of the gripping part has a pair of side portions facing each other and a pair of arc portions connecting end parts of the pair of side portions to each other (FIG. 4).
With respect to claim 5, Takahashi teaches the side portion is an arc curve having a curvature radius larger than a curvature radius of the arc portion (FIG. 4).
With respect to claim 7, Takahashi teaches a connecting portion between the side portion and the arc portion has a rounded shape without a corner portion (FIG. 4).
With respect to claim 8, Takahashi teaches the gripping part includes a first sleeve portion that is provided on a side of the tube body, and
a second sleeve portion that is provided on a side of the first sleeve portion opposite to the side of the tube body and that has an outer shape smaller than an outer shape of the first sleeve portion, and
an outer peripheral surface of at least one of the first sleeve portion or the second sleeve portion has the pair of side portions and the pair of arc portions (FIG. 3).
With respect to claim 11, Takahashi teaches the second sleeve portion has a length in the axial direction shorter than a length of the first sleeve portion in the axial direction (FIG. 3).
With respect to claim 12, Takahashi teaches the gripping part comprises an insertion port forming portion that is provided on a side of the second sleeve portion opposite to a side of the first sleeve portion, that has a funnel-like outer shape of which a diameter increases to the opposite side to the side of the first sleeve portion, and in which the insertion port is formed (FIG. 3).
With respect to claim 15, Takahashi teaches a flange portion (area of 79) that has an outer shape larger than the first sleeve portion (distal to flange portion) and the second sleeve portion (proximal to flange portion), between the first sleeve portion and the second sleeve portion (FIG. 3).
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.
Claim(s) 3, 9, 10, 13, 14, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi (U.S. 2021/0145258) in view of Kucklick et al. (U.S. 2005/0192532).
With respect to claim 3, Takahashi teaches two surfaces facing each other (FIG. 4) in the direction orthogonal to the axial direction have the standardized shape.
However, Takahashi does not teach an additional two surfaces facing each other.
With respect to claim 3, Kucklick et al. teaches on an outer peripheral surface of a gripping part, two surfaces face each other in a pair in the direction orthogonal to the axial direction have the standardized shape (FIG. 23).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Takahashi to include the two additional standardized surfaces as taught by Kucklick et al. in order to provide a means fro widening the proximal opening of the grip in order to make it easier to insert the instrument (para [0061]-[0062] of Kucklick et al.).
With respect to claim 9, Kucklick et al. teaches an outer peripheral surface of each of the first sleeve portion and the second sleeve portion has the pair of side portions and the pair of arc portions (FIG. 23).
With respect to claim 10, Takahashi in view of Kucklick et al. teaches in cross-sectional view that is viewed from the direction orthogonal to the axial direction, the outer peripheral surface of the first sleeve portion and the outer peripheral surface of the second sleeve portion have shapes similar to each other (FIG. 4 of Takahashi, FIG. 23 of Kucklick et al.).
With respect to claim 13, Takahashi in view of Kucklick et al. teaches an outer peripheral surface of each of the first sleeve portion, the second sleeve portion, and the insertion port forming portion has the pair of side portions and the pair of arc portions (FIG. 4 of Takahashi, FIG. 23 of Kucklick et al.).
With respect to claim 14, Takahashi in view of Kucklick et al. teaches in cross-sectional view that is viewed from the direction orthogonal to the axial direction, the outer peripheral surface of the first sleeve portion, the outer peripheral surface of the second sleeve portion, and the outer peripheral surface of the insertion port forming portion have shapes similar to each other (FIG. 4 of Takahashi, FIG. 23 of Kucklick et al.).
With respect to claim 17, Takahashi in view of Kucklick et al. teaches wherein in cross-sectional view that is viewed from the direction orthogonal to the axial direction, the outer peripheral surface of the gripping part has a shape of which curvature continuously changes along a circumferential direction (FIG. 4 of Takahashi, FIG. 23 of Kucklick et al.).
With respect to claim 18, Takahashi in view of Kucklick et al. teaches the gripping part comprises a first sleeve portion that is provided on a side of the tube body, and
a second sleeve portion that is provided on a side of the first sleeve portion opposite to the side of the tube body and that has an outer shape smaller than an outer shape of the first sleeve portion, and
an outer peripheral surface of at least one of the first sleeve portion or the second
sleeve portion has a pair of side portions and a pair of arc portions (FIG. 4 of Takahashi, FIG. 23 of Kucklick et al.).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi (U.S. 2021/0145258).
With respect to claim 6, Takahashi does not teach the side portion is a straight line. However, it would have been obvious to modify the side portion to have a straight line shape because a change in shape has been held to be within the level of one of ordinary skill in the art (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi (U.S. 2021/0145258) in view of Henzler et al. (U.S. 2015/0133736).
Takahashi teaches an insertion assisting tool as set forth above. However, Takahashi does not teach a leakage prevention valve.
With respect to claim 16, Henzler et la. teaches an insertion port forming portion comprises a leakage prevention valve (36) that prevents a liquid which has passed through the insertion pipe line from flowing out from the insertion port.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Takahashi to include the leakage prevention valve as taught by Henzler et al. in order to allow relatively easy insertion of the surgical instrument while still resisting the passage of fluids in the other direction (para [0047] of Henzler et al.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexandra Newton Surgan whose telephone number is (571)270-1618. The examiner can normally be reached Monday-Friday 8am-4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael 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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/ALEXANDRA L NEWTON/Primary Examiner, Art Unit 3799
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