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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 13th, 2026 has been entered.
Response to Amendment
Applicant’s amendments to the Claims have overcome the 112(b) rejections previously set forth in the Final Rejection mailed December 23rd, 2025.
Response to Arguments
Applicant’s arguments, see pages 11-15, filed March 13th, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive in view of the amendment and arguments submitted. Therefore, the rejection has been withdrawn.
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 2-3, 13 & 18-20 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.
Regarding claim 2, the claim recites “a flange” in line 4 and it is unclear whether this is the same flange or a different flange from that recited in claim 1, from which claim 2 depends. For examination purposes, these are the same flanges and the limitation will be interpreted as “the flange”.
Regarding claim 2, the claim recites “a tube” in line 7 and it is unclear whether this is the same tube or a different tube from that recited in claim 1, from which claim 2 depends. For examination purposes, these are the same tubes and the limitation will be interpreted as “the tube”. Additionally, the limitation reciting “a tube connected to the electrode, the tube configured to move in the sheath” in lines 7-8, it is unclear how this further limits the subject matter recited in claim 1.
Claims 3, 13 & 19 are also rejected by virtue of its dependency on claim 2.
Regarding claim 3, the claim recites “a connector” in line 4 and it is unclear whether this is the same connector or a different connector from that recited in claim 1, from which claim 3 depends. For examination purposes, these are the same connectors and the limitation will be interpreted as “the connector”.
Claim 18 is also rejected by virtue of its dependency on claim 3.
Regarding claim 18, the claim recites “a sheath body” in line 3 and it is unclear if this is the same as the sheath main body recited in claim 1, from which claim 18 depends, or is a different sheath body. For examination purposes, these are the same features and the limitation in this line and in line 4 will be interpreted as “the sheath main body”. Additionally, the recitation of “the sheath main body” under this interpretation makes it unclear how this limitation further limits the subject matter in claim 1.
Regarding claim 18, the claim recites “a distal end part” in line 4 and it is unclear if this is the same as the distal member recited in claim 1, from which claim 18 depends, or is a different distal end part. For examination purposes, these are the same features and the limitation in line 4, 10 & 12 will be recited as “the distal end part”. Additionally, the recitation of “the distal member” under this interpretation and the recitation of “fixed to a distal portion of the sheath body” makes it unclear how this limitation further limits the subject matter in claim 1.
Regarding claim 20, the claim recites “a flange” in line 3 and it is unclear whether this is the same flange or a different flange from that recited in claim 1, from which claim 20 depends. For examination purposes, these are the same flanges and the limitation will be interpreted as “the flange”.
Regarding claim 20, the claim recites “a tube” in line 4 and it is unclear whether this is the same tube or a different tube from that recited in claim 1, from which claim 20 depends. For examination purposes, these are the same tubes and the limitation will be interpreted as “the tube”.
Regarding claim 20, the claim recites “a connector” in line 6 and it is unclear whether this is the same connector or a different connector from that recited in claim 1, from which claim 20 depends. For examination purposes, these are the same connectors and the limitation will be interpreted as “the connector”. Additionally, the limitation reciting “a connector connecting the electrode and the tube” in line 6, it is unclear how this further limits the subject matter recited in claim 1.
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 29 is rejected under 35 U.S.C. 103 as being unpatentable over Tang et al. (U.S. Pub. No. 20210113260, cited in IDS), herein referred to as “Tang” in view of Jeon (U.S. Pub. No. 20200390494), herein referred to as “Jeon”.
Regarding claim 29, Tang discloses an endoscope treatment tool (Abstract: Dual-channel injection bipolar high frequency electrosurgical knife), comprising:
a sheath (insulation sheath 25) including a sheath main body (main body of insulation sheath 25) and a distal member (insulating part 12) fixed the sheath main body (see Figs. 1-2 where the insulation sheath abuts insulating part 12);
an electrode (inert electrode 13);
a needle (active electrode 11) inserted into the electrode (see Fig. 1); and
a flange is fixed to the needle (see Fig. 2 where the active electrode 11 comprises a widened section which is seen as a flange),
wherein a proximal end of the needle is located between a proximal end of the distal member and a distal end of the flange (see Fig. 2).
But Tang fails to disclose an electrode configured to pass through the distal member.
However, Jeon discloses an electrode (first knife 700) configured to pass through the distal member (discharge guide 640) ([0081]: The fluid discharge hole 642 is preferably formed in the center of the discharge guide 640, the size of the diameter of the fluid discharge hole 642 is formed larger than the diameter of the first knife 700 so that the first knife 700 may pass through). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrode of Tang to the electrode configuration of Jeon, for the purpose of enabling horizontal directional cutting that may be stably performed by the first knife (Jeon: [0073]).
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Tang in view of Jeon as applied to claim 29 above, and further in view of Oyatsu (U.S. Pub. No. 20080027429, previously cited), herein referred to as “Oyatsu”.
Regarding claim 30, Tang in view of Jeon fails to disclose wherein, in a retracted state, a distal most end of the needle is located proximally relative to a proximal end of the electrode and is located within a tube.
However, Oyatsu discloses wherein, in a retracted state, a distal most end of the needle (electrosurgical knife 10) is located proximally relative to a proximal end of the electrode (RF current conductors 14) and is located within a tube (flexible sheath 2) (see Fig. 4; [0037]: In case the slider 6 is moved rearward from the incisive position into a position shown with the virtual lines in the figure, the electrosurgical knife 10 is completely retracted in the flexible sheath 2 as shown in FIG. 4). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the needle of Tang in view of Jeon such that in a retracted state, a distal end of the needle is located proximally relative to the proximal end of the electrode, as taught by Oyatsu, for the purpose of in this position, exfoliation is possible to perform on a mucous membrane under the supply of a radio-frequency current to RF current conductors (Oyatsu: [0037]).
Regarding claim 31, Tang in view of Jeon and Oyatsu disclose wherein the tube has electrical insulation properties (Oyatsu: [0036]: a flexible sheath 2 made up by an elongate insulation tube).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Tang in view of Jeon and Oyatsu as applied to claim 30 above, and further in view of Zhou et al. (U.S. Pub. No. 20180368909), herein referred to as “Zhou”.
Regarding claim 32, Tang in view of Jeon and Oyatsu fail to disclose wherein the flange has a width greater than an inner diameter of a proximal end of the electrode in a direction perpendicular to a longitudinal axis of the sheath, and
wherein in an advanced state, a distal end of the needle is located distally relative to a distal end of the electrode and the flange is located within a connector located between the electrode and the tube.
However, Zhou discloses wherein the flange (mandrel connecting member 109) has a width greater than an inner diameter of a proximal end of the electrode in a direction perpendicular to a longitudinal axis of the sheath ([0042]: As shown in FIG. 1 to FIG. 3, the outer diameter of the mandrel connecting member 109 is larger than the aperture of a hollow portion 105-1 inside the spray head 105, so that when the first electrode 102 extends out, the mandrel connecting member 109 is stopped by the spray head 105, deciding an extension length of the first electrode 102), and
wherein in an advanced state, a distal end of the needle is located distally relative to a distal end of the electrode (electrode 104; see Fig. 2) and the flange is located within a connector (hose 108) located between the electrode (second electrode 104) and the tube (tube 106) (see fig. 2 where the flange 109 is within a connector 109 located between the electrode 104 and the tube 106). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the endoscope treatment tool of Tang in view of Jeon and Oyatsu to the configuration taught by Zhou for the purpose of the flange deciding an extension length of the first electrode (Zhou: [0042]).
Allowable Subject Matter
Claims 1, 5, 10-11, 22 & 24-28 allowed.
Claim 2-3, 13, 18-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794