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.
Response to Amendment
Acknowledgement is made to the amendment received 12/03/2025.
Acknowledgement is made to the amendment of claims 1-2 and 4-10.
Acknowledgement is made to the cancellation of claim 3.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1-2 and 4-10 are pending. A complete action on the merits appears below.
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.
Claim 1-2, 4, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Okada (US 20140288554 A1) in view of Hancock (US 20170014184 A1), Tang (US 20210113260 A1), and Wei (US 20130130541 A1).
Regarding claim 1, Okada teaches an electrode assembly (Fig. 1; high frequency knife 1) for endoscopic surgery, comprising an electrode core wire ([0012]- [0013], [0049] teach Fig. 1 as containing the high frequency knife having a sheath with a distal portion, containing an electrode and an electrically connecting wire portion), a telescopic control member (Fig. 1; operating section 35), and an insulating outer sleeve (Fig. 1; insulating tube 12), wherein
the electrode core wire ([0012]- [0013], [0049] teach Fig. 1; as containing the high frequency knife having a sheath 10 with a distal portion, containing an electrode and electrically connecting wire portion) comprises an electrode tip (Fig. 1; electrode portion 25 containing rod shaped electrode 26), a cable (Fig. 1; operating wire 20), and an electrode tube (Fig. 1; stopper receiving portion 21), wherein the electrode tip (Fig. 1; electrode portion 25 containing rod-shaped electrode 26) is electrically coupled to an output end of an external host through the cable ([0076]- [0077]), and the electrode tube sleeves on the electrode tip ([0060]- [0062]);
the insulating outer sleeve movably sleeves on the outside of the electrode core wire ([0049]- [0050]), and one end of the insulating outer sleeve where the electrode tip is located is a preset distance longer than the electrode tube ([0061]- [0062], [0078]);
the telescopic control member is configured to control the movement of the insulating outer sleeve so that the electrode tip extends out of the insulating outer sleeve or retracts into the insulating outer sleeve ([0049]- [0050], [0074]- [0075]).
However, Okada fails to teach the cable as being a coaxial cable.
Hancock teaches an electrosurgical device having at least one electrode for providing RF energy to tissue (Abstract, [0010]).
Hancock further teaches the RF energy as being conveyed to the distal end of a probe tip comprising an electrode by a coaxial cable ([0010]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the operating wire which provides high-frequency voltage to an electrodes from a high-frequency generator as is taught by Okada with the coaxial cable for conveying radiofrequency energy to the distal end of the probe tip comprising an electrode as is taught by Hancock, to produce the predictable result of providing an electrode with radiofrequency energy as it has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Okada further fails to teach the electrode tube as being an electrode insulating tube.
Tang teaches a telescopic electrode assembly having an electrode part, containing an active electrode which is connected to a connection cable by a connector ([0029]).
Tang further teaches this connector as being covered by an insulating tubular element which is referred to as a seal, which provides for distal restriction when the seal touches a distal insulating portion of the main portion of the sheath of the device ([0041], [0044]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted stopper-receiving portion, as is taught by Okada with the seal covering the distal portion of the connector as is taught by Tang, to produce the predictable result of a tubular element covering the electrical wire to provide distal restriction as is taught, as it has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
However, Okada as modified fails to teach the coaxial cable comprising a center conductor, and an insulating later, a conducting layer, and an outer insulating skin that sequentially sleeve on the center conductor from inside to outside, and an end face of the conducting layer is flush with an end face of the outer insulating skin; an end portion of the center conductor and an end portion of the insulating layer are located inside the electrode insulating tube, and the conducting layer and the outer insulating skin are located outside the electrode insulating tube.
Okada as currently modified by Hancock, further teaches the cable as being a coaxial cable (see above provided rejection).
Wei teaches an electrical signal connector which is to be used with a coaxial cable, wherein the signal connector is attached at a at a distal end of the coaxial cable ([0034]).
The coaxial cable is discussed as having a center conductor surrounded by an inner dielectric insulator, a metal wrapper, and an outer plastic sheath, where the metal wrapper and the outer plastic sheath are compressed to deform and to squeeze against the same point, and the inner dielectric insulator and the metal wrapper as being separated by a barbed flange of the core tube ([0034]- [0035]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the structure of the coaxial cable as is taught by Wei, into the coaxial cable which provides energy to an electrode as is taught by Hancock, to produce the predictable result of using a coaxial cable to provide energy to a signal connecting element, as is taught by Wei, 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).
Further, Okada as currently modified therefore teaches the center conductor being configured to connect with the electrode tip as it should be understood within a broadest reasonable interpretation that all elements of an apparatus as modified “connect” to all other elements of that same embodiment as modified, such as by being directly connected, indirectly connected, electrically connected, etc.) and that the electrode tip and the conducting layer are arranged in a front-to-back configuration along an axis direction of the electrode assembly ([0060] teaches the electrode as being connected to the distal end portion of the operating wire, the conducting wire is substituted for the coaxial cable, which contains said conducting layer).
Regarding claim 2, Okada teaches the electrode assembly for endoscopic surgery according to claim 1, wherein the electrode tip is of needle shape (Fig. 1; electrode portion 25 containing rod-shaped electrode 26).
Regarding claim 4, Okada further teaches the electrode assembly for endoscopic surgery according to claim 3, wherein the electrode core wire further comprises an insulating inner sleeve (Fig. 1; insulated chip 15) which seals and sleeves on the outside of the electrode tube and the outside of the outer insulating skin ([0049], [0055]- [0056]);
the insulating outer sleeve slidably sleeves on the outside of the insulating inner sleeve ([0049]- [0050]).
Regarding claim 8, Okada teaches the electrode assembly for endoscopic surgery according to claim 4, wherein the insulating inner sleeve and the insulating outer sleeve are smooth sleeves with preset flexibility and rigidity and the insulating outer sleeve is made up of organic polymer material ([0052]).
Okada further teaches the insulated chip which is located at the distal end of the insulating tube and telescopically surrounds the electrode portion as being formed of an insulating material ([0055], [0057]).
However, Okada fails to teach the insulating inner sleeve as being made up of organic polymer material.
Tang teaches an insulating part which is located at the distal end of the outer insulation sheath and telescopically surrounds the active electrode as being formed of an insulating material ([0008], [0029]).
Tang further teaches the insulating material as being a material which has both heat resistance and insulation such as polytetrafluoroethylene, also known as PTFE ([0008]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the insulating material of the insulated chip as is taught by Okada with the PTFE which has both heat resistance and insulation of the insulating part as is taught by Tang as both materials perform the same function of providing insulation to an insulating element which is located at the distal end of an outer sheath and telescopically surround an 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).
Regarding claim 9, the modified teachings of Okada teaches the electrode assembly for endoscopic surgery according to claim 4.
However, the modified teachings of Okada do not specifically teach the electrode assembly wherein the coaxial cable, the electrode insulating tube, the insulating inner sleeve, and the insulating outer sleeve are integrally molded.
However, Applicant has not disclosed that these components being integral produces an unexpected result and it has been held that integration of parts is an obvious modification (MPEP 2144.04(V)(B)).
Regarding claim 10, Okada as modified further teaches the electrode assembly for endoscopic surgery according to claim 1, wherein a sealing member is filled between the electrode tip and the electrode insulating tube (Fig. 1; stopper member 13 is positioned along the longitudinal axis between the distal portion large-diameter portion 27 of the electrode portion 25 and the stopper receiving portion 21 as broadly as is claimed), between the insulating inner sleeve and the coaxial cable (Fig. 1; stopper member 13 is positioned along the longitudinal axis between the insulated chip 15 and the operating wire 20 as broadly as is claimed), and between the electrode insulating tube and the coaxial cable (Fig. 1; stopper member 13 fills the interior of the insulating tube at a radial position between the stopper receiving portion 21 and the operating wire 20 as broadly as is claimed).
Claim 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Okada (US 20140288554 A1) in view of Hancock (US 20170014184 A1), Tang (US 20210113260 A1), and Wei (US 20130130541 A1) further in view of Yahagi (US 20080269558 A1).
Regarding claim 5, Okada teaches the electrode assembly for endoscopic surgery according to claim 1, wherein the electrode core wire further comprises a coaxial connector (Fig. 1; connecting connector 38);
the telescopic control member comprises a tubular body (Fig. 1; operating section body 36), a movable member (Fig. 1; operating slider 37), an end cap (Fig. 1; finger-hooking ring 36a);
the movable member (Fig. 1; operating slider 37) axially movably sleeves on an end portion of the tubular body (Fig. 1; operating section body 36);
the end cap (Fig. 1; finger-hooking ring 36a) is fixed to the other end portion of the tubular body (Fig. 1; operating section body 36) and is connected to the coaxial connector;
the cable passes through the movable member and the fixed tube ([0076]- [0077]), and thereafter is electrically coupled to the coaxial connector and the output end of the external host ([0076]- [0077]);
the movable member is connected to the insulating outer sleeve (It should be understood within a broadest reasonable interpretation that all elements of an apparatus are “connected to” all other elements of that same embodiment, either directly, indirectly, electrically, etc.).
However, Okada fails to teach the electrode assembly comprising a fixed tube and the coaxial connector and the fixed tube being disposed inside the tubular body.
Yahagi teaches an instrument having a high frequency knife at a distal end of a wire ([0033]- [0034]) which is connected to a high-frequency power supply by a plug ([0044]- [0045]).
Yahagi further teaches this wire as having the proximal end being inserted within a buckle preventative pipe and this buckle preventative pipe and wire as being connected to the plug within the main body of a maneuvering section ([0044]- [0045]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the plug and the buckle preventative pip as being located within the main body of the maneuvering section, as is taught by Yahagi, into the operating section which contains a connector which electrically connects to the proximal end side of the operating wire as is taught by Okada, to produce the predictable result of electrically connecting a high frequency knife with a high frequency power supply, as is taught by Yahagi, 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 6, the modified device of Okada teaches the electrode assembly for endoscopic surgery according to claim 5.
However, the modified device of Okada fails to teach the electrode assembly wherein the telescopic control member further comprises a locating pin;
the movable member is provided with a locating hole for fixing the locating pin;
the tubular body is provided with a guiding groove in which the locating pin is slidably provided.
Yahagi further teaches the first maneuvering member as being provided with a guide groove containing a fixture dial which engages through the first maneuvering member to be fixed to the main body ([0046]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the fixture dial for fixing the first maneuvering member at an arbitrary position on the main body as is taught by /Yahagi into the operating section of Okada to produce the predictable result of being able to fix the maneuvering of the device at an arbitrary position, as is taught by Yahagi, 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, Okada further teaches the electrode assembly for endoscopic surgery according to claim 5, wherein the movable member is threadedly engaged with the tubular body ([0073]).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Okada/Hancock/Tang reference are moot in view of the new rejections under Okada/Hancock/Tang and Wei.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794
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