DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/22/2025 has been entered.
Notice of Pre-AIA or AIA Status
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.
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, 7, and 12-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kadoch, (US 20040092986).
Regarding claim 1, Kadoch (Figure 5) discloses an electrode unit (3) comprising: two electrode support members (40) separated in a direction along a predetermined axis, each of the two electrode support members (40) extending parallel to the predetermined axis and being fixed relative to each other; a base part (base body of device shown as element 32 in Figures 3A/3B) extending along an axis intersecting with the predetermined axis, and having a distal end coupled with proximal ends of the two electrode support members (40); a conductive wire (37) extending through an inside of each of the two electrode support members (40); and an electrode (7a) electrically connected to a distal end of the wire (37) of each of the two electrode support members (40), the electrode (7a) having a central (U-shaped) portion extending in the direction from opposing side surfaces of the two electrode support members (40); wherein the two electrode support members (40) each include a distal-most portion (42) protruding distally relative to the central (U-shaped) portion of the electrode (7a) such that each distal-most portion (42) is configured to restrict a depth by which the central (U-shaped) portion of the electrode (7a) sinks into a wall surface of an organ when a distal end of the distal-most portion (42) of each of the two electrode support members (40) is pushed against the wall surface of the organ ([0041]-[0042]).
Regarding claim 7, Kadoch (Figure 5) further discloses wherein the two electrode support members (40) are each inclined at a same predetermined angle and direction relative to a longitudinal axis of the base part ([0041]-[0042]).
Regarding claim 12, Kadoch (Figure 5) further discloses wherein the central (U-shaped) portion of the electrode (7a) has a linear shape (in a perpendicular axis to the longitudinal axis) which is parallel to a second (perpendicular) axis orthogonal to a first (longitudinal) axis along the two electrode support members (40), and a profile of the distal-most portion (42) of each of the two electrode support members (40) has a circular columnar shape with the central (U-shaped) portion of the electrode (7a) extending parallel to a center axis of each circular columnar shape ([0041]-[0042]).
Regarding claim 13, Kadoch (Figure 5) further discloses wherein the central (U-shaped) portion of the electrode (7a) has a linear shape (in a perpendicular axis to the longitudinal axis) which is parallel to a second (perpendicular) axis orthogonal to a first (longitudinal) axis along the two electrode support members (40), and a profile of the distal-most portion (42) of each of the two electrode support members (40) has a spherical shape, and a center axis of the central (U-shaped) portion of the electrode (7a) extends between a center of each spherical shape ([0041]-[0042]).
Regarding claim 14, Kadoch (Figure 5) further discloses wherein the central (U-shaped) portion of the electrode (7a) is entirely disposed so as to be contained within a projection of the two electrode support members (40) when viewed along the predetermined axis ([0041]-[0042]).
Regarding claim 15, Kadoch (Figure 5) further discloses wherein the distal-most portion (42) of each of the two electrode support members (40) comprises a cut-out (through which element 7a is held) disposed on the opposing side surface ([0041]-[0042]).
Regarding claim 16, Kadoch (Figure 5) further discloses wherein the cut-out (though which element 7a is held) opens from a distal-most surface (42) of the each of the two electrode support members (40), ([0041]-[0042]).
Regarding claim 17, Kadoch (Figure 5) further discloses wherein end portions (proximal portions of element 7a held in the cut-outs) of the electrode (7a) are disposed in the cut-out ([0041]-[0042]).
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.
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kadoch, as applied to claim 1 above, and further in view of Schouenborg et al., (US 20180369572; hereinafter Schouenborg).
Regarding claim 5, Kadoch discloses the electrode unit according to claim 1, but fails to disclose wherein the distal-most portion of each of the two electrode support members has a spherical shape. However, Schouenborg (Figure 1c) teaches an electrode unit (21) wherein the distal-most portion (24) of an electrode support member (23’) has a spherical shape ([0069]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the cylindrical/rounded shape of the distal-most portion of each of the two electrode support members disclosed by Kadoch with the spherical shape of the distal-most portion of the electrode support member taught by Schouenborg since both distal-most portion shapes perform the same function of contacting tissue and separating tissue at the distal end of the device from the electrode, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Claim(s) 6, 9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kadoch, as applied to claim 1 above, and further in view of Yahagi et al., (US 20070282328; hereinafter Yahagi).
Regarding claim 6, Kadoch discloses the electrode unit according to claim 1, but fails to disclose wherein at least an exterior surface of the distal-most portion of the two electrode support members is made of an elastic material. However, Yahagi (Figure 3) teaches an electrode unit (1), wherein the distal-most portion (corresponding to element 10) of two electrode support members (3A, 3B) is made of an elastic material ([0048]-[0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kadoch to include at least an exterior surface of the distal-most portion of the two electrode support members made of an elastic material, as taught by Yahagi, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Regarding claim 9, Kadoch discloses the electrode unit according to claim 1, but fails to disclose a resectoscope apparatus comprising: a sheath configured to be inserted into a subject and having a hollow shape; a telescope including an insertion portion inserted into the sheath; an electrode unit holding part configured to hold the electrode unit in the sheath; and a scope holding part configured to hold the insertion portion of the telescope in the sheath at a position in a second direction with respect to the two electrode support members of the electrode unit, the second direction being opposite to a first direction in which the two electrode support members are configured to be pushed against the wall surface during use of the electrode unit. However, Yahagi (Figure 3) teaches a resectoscope apparatus comprising: a sheath (2) inserted into a subject and having a hollow shape; a telescope (6) including an insertion portion (operating wire) inserted into the sheath (2); an electrode unit holding part (7) configured to hold an electrode unit (1) in the sheath (2); and a scope holding part (15) configured to hold the insertion portion (operating wire) of the telescope (6) in the sheath (2) at a position in a second direction with respect to the two electrode support members (3A, 3B) of the electrode unit (1), the second direction being opposite to a first direction in which the two electrode support members (3A, 3B) are configured to be pushed against the wall surface during use of the electrode unit (1), ([0048]-[0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kadoch to include a resectoscope apparatus comprising: a sheath configured to be inserted into a subject and having a hollow shape; a telescope including an insertion portion inserted into the sheath; an electrode unit holding part configured to hold the electrode unit in the sheath; and a scope holding part configured to hold the insertion portion of the telescope in the sheath at a position in a second direction with respect to the two electrode support members of the electrode unit, the second direction being opposite to a first direction in which the two electrode support members are configured to be pushed against the wall surface during use of the electrode unit, as taught by Yahagi, since Kadoch discloses that the electrode unit may be used in particular for various applications and in particular for effecting endoscopic resections (Kadoch; [0042]) requiring a resectoscope apparatus.
Regarding claim 11, Kadoch discloses the electrode unit according to claim 1, but fails to disclose wherein at least a surface of each of the two electrode support members is made of a material having an electrical insulating property. However, Yahagi (Figure 3) teaches an electrode unit (1), wherein at least a surface of each of the two electrode support members (3A, 3B) is made of a material having an electrical insulating property ([0048]-[0052]: elements 3A and 3B must be made of a material having an electrical insulating property since they carry the conductive wire 5 and would cause a short if they carry the conductive wire 5 without being electrically insulating). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the insulated wire+conductive support arm configuration disclosed by Kadoch with the conductive wire+insulated support arm configuration taught by Yahagi, because both configurations perform the same function of providing a channel for the conductive wire to exit at the distal end of the support arms to form the electrode, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yahagi, as applied to claim 7 above, and further in view of Grossi et al., (US 6197025; hereinafter Grossi).
Regarding claim 8, Yahagi discloses the electrode unit according to claim 7, but fails to disclose two arm parts coupled with proximal ends of the two electrode support members, and coupled with a distal end of the base part, wherein each of the two arm parts includes: a first bent portion which is bent so as to extend in a second direction as the first bent portion extends from a proximal end toward a distal end, the second direction being opposite to a first direction in which the two electrode support members are configured to be pushed against the wall surface during the use of the electrode unit; a second bent portion which is provided on a distal end side of the first bent portion, and which is bent so as to extend in the first direction as the second bent portion extends toward the distal end; and a third bent portion which is provided on a distal end side of the second bent portion and on a first direction side of the distal end of the base part, and which is bent to the predetermined angle so as to extend in the second direction as the third bent portion extends toward the distal end, and the elastic support member is disposed between the second bent portion and the third bent portion of each of the two arm parts. However, Grossi (Figure 28) teaches an electrode unit in which the proximal ends of two electrode support members (256) are coupled with two arm parts (proximal bent part comprising elements A+B+C in annotated Figure 28 below), wherein the two arm parts (proximal bent part comprising elements A+B+C) are coupled with a distal end of a base part (base part proximal to the proximal bent part comprising elements A+B+C in annotated Figure 28 below), wherein each of the two arm parts (proximal bent part comprising elements A+B+C) includes: a first bent portion (A in annotated Figure 28 below) which is bent so as to extend in a second direction as the first bent portion (A) extends from a proximal end toward a distal end, the second direction being opposite to a first direction in which the two electrode support members (256) are configured to be pushed against the wall surface during the use of the electrode unit; a second bent portion (B in annotated Figure 28 below) which is provided on a distal end side of the first bent portion (A), and which is bent so as to extend in the first direction as the second bent portion (B) extends toward the distal end; and a third bent portion (C in annotated Figure 28 below) which is provided on a distal end side of the second bent portion (B) and on a first direction side of the distal end of the base part (base part proximal to the proximal bent part comprising elements A+B+C), and which is bent to a predetermined angle so as to extend in the second direction as the third bent portion (C) extends toward the distal end, and the elastic support member (256) is disposed between the second bent portion and the third bent portion of each of the two arm parts (proximal bent part comprising elements A+B+C), (Col. 14, lines 16-24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yahagi to include two arm parts coupled with proximal ends of the two electrode support members, and coupled with a distal end of the base part, wherein each of the two arm parts includes: a first bent portion which is bent so as to extend in a second direction as the first bent portion extends from a proximal end toward a distal end, the second direction being opposite to a first direction in which the two electrode support members are configured to be pushed against the wall surface during the use of the electrode unit; a second bent portion which is provided on a distal end side of the first bent portion, and which is bent so as to extend in the first direction as the second bent portion extends toward the distal end; and a third bent portion which is provided on a distal end side of the second bent portion and on a first direction side of the distal end of the base part, and which is bent to the predetermined angle so as to extend in the second direction as the third bent portion extends toward the distal end, and the elastic support member is disposed between the second bent portion and the third bent portion of each of the two arm parts, as taught by Grossi, since applicant has not disclosed that having the two arm parts solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the arm parts, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
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Annotated Figure 28 from the Grossi reference
Response to Arguments
Applicant’s arguments filed 12/22/2025, with regard to the newly amended claim limitations, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art reference Kadoch, which teaches an electrode unit comprising an electrode having a central portion extending from opposing inner side surfaces of two electrode support members, wherein each of the two electrode support members extend parallel to the predetermined axis and being fixed relative to each other. Therefore, Kadoch teaches the invention as claimed at least in amended independent claim 1.
Conclusion
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794