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 .
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 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.
Status of the Claims
The current office action is made responsive to claims filed 01/09/2025.
Claims 1-20 are pending. A complete action on the merits appears below.
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.
Claims 1-5 and 13-14 are rejected under 35 U.S.C. 102 as being anticipated by Suzuki (US 20120220993 A1).
Regarding claim 1, Suzuki teaches an endoscope treatment tool (Fig. 1; treatment device 1), comprising:
a sheath (Fig. 1-2B; cylindrical sheath 11);
a first rod (Fig. 1-2B; second electrode 52) protruding from a distal end of the sheath ([0068]);
an insulator (Fig. 1-2B; insulator 53) fixed to a distal end of the first rod; and
a second rod (Fig. 1-2B; first electrode 51) extending to a distal side from the insulator ([0062]), wherein the first rod and the second rod are conductive ([0062]), and wherein the second rod is fixed relative to the insulator in a position along a longitudinal axis of the first rod ([0062]).
Regarding claim 2, Suzuki teaches the endoscope treatment tool according to claim 1, wherein an outer diameter of at least a portion of the second rod is equal to or smaller than an outer diameter of the first rod ([0063]).
Regarding claim 3, Suzuki teaches the endoscope treatment tool according to claim 1, wherein a length between a distal end of the insulator and a distal end of the second rod is smaller than a protruding length of the first rod from the sheath (Fig. 2B; the length of the first electrode 51 is shown as being smaller than the length of the second electrode 52 out of the sheath 11; [0064]- [0065], [0068]).
Regarding claim 4, Suzuki teaches the endoscope treatment tool according to claim 1, wherein the second rod is fixed to the insulator ([0007], [0098]).
Regarding claim 5, Suzuki teaches the endoscope treatment tool according to claim 1, wherein the second rod is connected to a wire (Fig. 2B; conductive wire 54) passing through an inside portion of the first rod ([0069]), and wherein the wire is conductive ([0067]).
Regarding claim 13, Suzuki teaches an endoscope treatment tool (Fig. 1; treatment device 1), comprising:
a sheath (Fig. 1-2B; cylindrical sheath 11);
a first rod (Fig. 1-2B; second electrode 52) protruding from a distal end of the sheath ([0068]);
an insulator (Fig. 1-2B; insulator 53) located at a distal end of the first rod; and
a second rod (Fig. 1-2B; first electrode 51) extending from the insulator ([0062]), wherein the first rod and the second rod are conductive ([0062]), and wherein the insulator, the first rod, and the second rod are configured to integrally advance and retract relative to the sheath between a first position where the first rod is advanced to its fullest extent and a second position where the first rod is retracted to its fullest extent ([0059], [0068]).
Regarding claim 14, Suzuki teaches the endoscope treatment tool according to claim 13, wherein a length between a distal end of the insulator and a distal end of the second rod is smaller than a maximum amount of protrusion of the first rod from the sheath (Fig. 2B; the length of the first electrode 51 is shown as being smaller than the length of the second electrode 52 out of the sheath 11; [0064]- [0065], [0068]).
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.
Claims 6-9 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki (US 20120220993 A1) in view of Miyajima (US 20060276784 A1).
Regarding claim 6, Suzuki teaches the endoscope treatment tool according to claim 1.
However, Suzuki fails to teach the endoscope treatment tool further comprising:
a switch selecting one of the first rod or the second rod as a current path.
Miyajima teaches an instrument for use within an endoscope having multiple electrodes (Fig. 2; first electrode section 6 and second electrode section 9) at a distal portion of an insertion section (Fig. 1-2; insertion section 5), wherein the second electrode is movably located within and distal to the first electrode section ([0048]- [0051]). This distal portion of the insertion section is provided with an external current to either of the first or second electrodes as is desired by the procedure ([0059]- [0060] discuss the current as being applied to treat patient tissue by the second electrode section, [0064]- [0066] discuss the current as being applied to treat patient tissue by the first electrode section).
Miyajima further teaches the external current being applied to the high-frequency device as being controlled by a switching device within the control section of a handle of the device, this switching of the current output between the electrodes is taught as allowing the operation to be easy and take little time ([0068], [0079]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of an element which controls the connection of the current output to either of two distal electrodes by switching the connection as being on a handle of an endoscope, as is taught by Miyajima, into the endoscope having multiple electrodes, as is taught by Suzuki, to produce the predictable result of switching the device output so as to allow for quick and easy operation, as is taught by Miyajima, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 7, Suzuki teaches the endoscope treatment tool according to claim 6, further comprising:
a handle (Fig. 1; handle 40) located at a proximal end of the sheath (Fig. 1-2B; cylindrical sheath 11).
In accordance with the above rejection of claim 6, Miyajima teaches the switch being located on the handle ([0068], [0078]- [0079]).
Regarding claim 8, Suzuki teaches the endoscope treatment tool according to claim 6, wherein the insulator, the first rod, and the second rod are configured to integrally advance and retract as an integral part relative to the sheath ([0059], [0068]).
In accordance with the above rejection of claim 6, Miyajima teaches the switch selecting one of the first rod or the second rod as the current path by advancing and retracting movement of the first rod ([0068], [0079]).
Regarding claim 9, Suzuki as currently modified teaches the endoscope treatment tool according to claim 6, wherein the insulator, the first rod, and the second rod are configured to advance and retract as an integral part relative to the sheath ([0059], [0068]), and
wherein the switch selects one of the first rod or the second rod as the current path independent of advancing and retracting movement of the first rod ([0091]- [0093] teaches the ability to apply high-frequency, this ability to apply treatment is independent of the specific position of the second electrode to the sheath, as broadly as is currently claimed).
Regarding claim 15, Suzuki teaches an endoscope treatment tool, comprising:
a sheath (Fig. 1-2B; cylindrical sheath 11);
a first rod (Fig. 1-2B; second electrode 52) protruding from a distal end of the sheath ([0068]);
an insulator (Fig. 1-2B; insulator 53) located at a distal end of the first rod;
a second rod (Fig. 1-2B; first electrode 51) extending from the insulator ([0062]), and wherein the first rod and the second rod are conductive ([0062).
However, Suzuki fails to teach the endoscope treatment tool as comprising: a switch configured to select one of the first rod or the second rod as an electric current path.
Miyajima teaches an instrument for use within an endoscope having multiple electrodes (Fig. 2; first electrode section 6 and second electrode section 9) at a distal portion of an insertion section (Fig. 1-2; insertion section 5), wherein the second electrode is movably located within and distal to the first electrode section ([0048]- [0051]). This distal portion of the insertion section is provided with an external current to either of the first or second electrodes as is desired by the procedure ([0059]- [0060] discuss the current as being applied to treat patient tissue by the second electrode section, [0064]- [0066] discuss the current as being applied to treat patient tissue by the first electrode section).
Miyajima further teaches the external current being applied to the high-frequency device as being controlled by a switching device within the control section of a handle of the device, this switching of the current output between the electrodes is taught as allowing the operation to be easy and take little time ([0068], [0079]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of an element which controls the connection of the current output to either of two distal electrodes by switching the connection as being on a handle of an endoscope, as is taught by Miyajima, into the endoscope having multiple electrodes, as is taught by Suzuki, to produce the predictable result of switching the device output so as to allow for quick and easy operation, as is taught by Miyajima, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 16, Suzuki teaches the endoscope treatment tool according to claim 15,wherein the second rod is connected to a wire (Fig. 2B; conductive wire 54) passing through an inside portion of the first rod ([0069]), and wherein the wire is conductive ([0067]).
Regarding claim 17, Suzuki teaches the endoscope treatment tool according to claim 15, further comprising: a handle (Fig. 1; handle 40) located on a proximal end of the sheath (Fig. 1-2B; cylindrical sheath 11).
In accordance with the above rejection of claim 15, Miyajima teaches the switch being located on the handle ([0068], [0078]- [0079]).
Regarding claim 18, In accordance with the above rejection of claim 15, Miyajima teaches the endoscope treatment tool according to claim 15, wherein the switch is configured to select one of the first rod or the second rod as the electric current path by advancing and retracting of the first rod ([0068], [0079]).
Regarding claim 19, Suzuki teaches the endoscope treatment tool of claim 15, wherein the insulator, the first rod, and the second rod are integrally configured to advance and retract relative to the sheath ([0059], [0068]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Suzuki (US 20120220993 A1) in view of Tang (US 20190262068 A1).
Regarding claim 10, Suzuki teaches the endoscope treatment tool according to claim 1, wherein a proximal end side of the first rod protruding from the sheath is covered with a member (Fig. 2B; contact member 13).
However, Suzuki fails to teach the member as being an insulating member.
Tang teaches a high-frequency electric knife for use with an endoscope (Abstract, [0044]), the knife having a cutter portion comprising an insulation sheath and two electrodes (Fig. 2; insulation sheath 6, first electrode portion 3 and second electrode portion 1).
Tang further teaches the insulation sheath as surrounding a position-limiting part comprising a fixed insulation part for position-limiting where this fixed insulation part for position-limiting is taught as being made of an insulation material, such as ceramic, which is resistant to high temperatures (Fig. 2; position-limiting part 5 and position-limiting 12; [0047]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the member which is located within the sheath and surrounds the first electrode portion as being a member which is made of a material which is insulative and resistant to high temperatures, as is taught by Tang, into the contact member which surrounds the second electrode as is taught by Suzuki, to produce the predictable result of providing an element which surrounds an electrode with a material which is insulative and resistant to high temperatures, as is taught by Tang, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki (US 20120220993 A1).
Regarding claim 11, Suzuki teaches the endoscope treatment tool according to claim 1.
While the currently cited embodiment of Suzuki does not teach the endoscope treatment tool further comprising:
an electrode connected to a distal end of the first rod, wherein the insulator is located distally relative to electrode, and wherein at least a part of the electrode protrudes outward from an outer surface of a proximal end of the insulator in a radial direction of the first rod.
Suzuki further teaches a configuration of the treatment device (Fig. 11) which contains an electrode extending portion (Fig. 11; extending portion 552a) which extends to the outside in the radial direction of the second electrode (Fig. 11; second electrode 552), this extending portion being provided so as to incise tissue, such as that of an aperture with high-frequency current ([0135], [0146]- [0147]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the extending portion which extends in the radial direction outside of the second electrode, as is taught by the configuration of Fig. 11 of Suzuki, into the second electrode, as is taught by the configuration of Fig. 2A-B of Suzuki, to produce the predictable result of incising desired tissue, as is taught by the configuration of Fig. 11 of Suzuki, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 12, in accordance with the above rejection of claim 11, Suzuki as modified teaches the endoscope treatment tool according to claim 11, wherein the electrode has a protrusion protruding outward from the outer surface of the proximal end of the insulator in the radial direction of the first rod, and wherein a maximum distance between a central axis of the second rod and an outer surface of the second rod in a front view from a longitudinal direction is smaller than a distance between a central axis of the first rod and a top of the protrusion of the electrode ([0135], [0146]- [0147]).
Claim 20 rejected under 35 U.S.C. 103 as being unpatentable over Suzuki (US 20120220993 A1) in view of Miyajima (US 20060276784 A1) and Zhou (US 20180368909 A1).
Regarding claim 20, Suzuki as modified teaches the endoscope treatment tool of claim 15.
However, Suzuki fails to teach the endoscope treatment tool wherein the second rod is configured to advance and retract relative to the insulator and the first rod.
Zhou teaches a multi-function high-frequency tool for an endoscope having an insulating sheath (Fig. 1-3; sheath 107), an elongated electrode (Fig. 1-3; second electrode 104) located within the sheath, an insulating portion (Fig. 1-3; insulating tip 101) located at the distal end of said electrode, and an additional elongated electrode (Fig. 1-3; first electrode 102) where the tissue contacting portion of the additional electrode (Fig. 1-3; first electrode 102) is located distal of the electrode (Fig. 1-3; second electrode 104) and the proximal most point of the insulating portion (Fig. 1-3; insulating tip 101).
Zhou further teaches these electrodes as being configured to advance and retract relative to a variety of other elements, such as being movably configured so that the insulating tip, and first and second electrodes are able to be integrally advanced and retracted, where they are movably positioned in the form of a unit with each other (Fig. 3), or where they may be able to be positioned individually where the first electrode is able to be advanced and retracted separately from the insulating tip and second electrode, so as to expose the first electrode (Fig. 2).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the ability for the distally positioned electrode to be movable individually in addition to being movable in unison with the proximally positioned electrode and insulating element, as is taught by Zhou, into the system having a distally positioned electrode, a proximally positioned electrode and an insulator, which are capable of being moved in unison as is taught by Suzuki, to produce the predictable result of providing additional manners of controlling a device as may be used within a procedure, such as to expose the distal electrode, as is taught by Zhou, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Conclusion
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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