DETAILED ACTION
Applicant's amendments and remarks, filed 3/30/26, are fully acknowledged by the Examiner. Currently, claims 1-16 are pending with claims 1 and 9 amended. The following is a complete response to the 3/30/26 communication.
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 (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 § 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) 1-2, 6-10, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siebrecht (US 2011/0087221) in view of Dumbauld (US 2007/0078458), in view of Mayer (US 2017/0065331), and in further view of Boudreaux (US 2017/0105754).
Regarding claim 1, Siebrecht teaches an end effector assembly for an electrosurgical instrument,
comprising: a pair of opposing first and second jaw members each including a jaw housing supporting an electrically conductive tissue sealing plate disposed thereon (jaw members 110 with jaw housings 114 and 124 and sealing plates 112 and 122), the electrically conductive tissue sealing plates of the first and second jaw members disposed in opposition relative to one another (as in at least Fig. 3), at least one of the first or second jaw member movable relative to the other jaw member to grasp tissue therebetween (at least par. [0043] tissue grasped between the jaw members), the electrically conductive tissue sealing plates of the first and second jaw members adapted to connect to opposite potentials of an electrosurgical energy source to deliver bipolar energy (par. [0034] bipolar from generator), the electrically conductive tissue sealing plate of the first jaw member having a longitudinally extending channel along a length thereof (par. [0012] T-shaped channel); and a blade disposed within the channel of the electrically conductive tissue sealing plate of the first jaw member and extending to a distal end portion thereof (blade 190 within channel as in par. [0046] and extending distally).
Siebrecht is silent regarding the blade as an electrode, the electrode fixed within the channel, and electrically connected to the energy source and independently activatable from the electrically conductive tissue sealing plates.
However, Dumbauld teaches using a cutting edge that can be a RF electrode for monopolar energy for cutting tissue (par. [0016] selectively energizable monopolar knife).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the blade as an electrode with insulated material as in Dumbauld, as a known energy delivery mechanism for the knife that would work to cut tissue grasped by jaws.
However, Mayer teaches using a cutting edge that can be a RF electrode that creates a plasma for cutting tissue with insulating material (Figs. 9a-c and par. [0039] with a cutting element with electrically insulating material on either side of a cutting electrode 26), and the cutting element fixed in a channel of the jaw (at least Fig. 9a).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with insulating material on either side of a knife as in Mayer, to prevent unwanted shorting. It would have further been obvious to modify Siebrecht with the cutting element fixed in the channel, as a way to deliver cutting energy while reducing the number of mechanisms in the device.
Siebrecht is silent regarding wherein the electrosurgical energy source is switchable between a bipolar mode and a monopolar mode based on a position of the first and second jaw members.
However, Boudreaux teaches a closure sensor associated with the jaw member to sense when the jaws are open or closed (par. [0342] detect closure angle of jaw relative to body), and communicating with electrical energy source to configure the instrument for a mode of operation depending on activation (par. [0342] control module in communication with sensor to select operation).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the sensor of Boudreaux to activate treatment depending on if tissues are grasped by the jaws.
Regarding claim 2, Siebrecht teaches wherein the electrically conductive tissue sealing plate of the second jaw member has an open T-shaped configuration defining a channel along a length thereof (par. [0012] T-shaped channel) and wherein an insulative member is disposed within the channel of the electrically conductive tissue sealing plate of the second jaw member in opposing vertical registration to the blade (119' and 129' as in par. [0053] in opposition to the blade).
Mayer teaches the electrode as in claim 1.
Regarding claim 6, Siebrecht is silent regarding a sensor operably associated with at least one of the jaw members and configured to sense when the jaw members are disposed in the open configuration, the sensor communicating with the electrical energy source to configure the electrosurgical instrument for monopolar use upon activation thereof.
However, Boudreaux teaches a closure sensor associated with the jaw member to sense when the jaws are open or closed (par. [0342] detect closure angle of jaw relative to body), and communicating with electrical energy source to configure the instrument for a mode of operation depending on activation (par. [0342] control module in communication with sensor to select operation).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the sensor of Boudreaux to activate treatment depending on if tissues are grasped by the jaws.
Regarding claim 7, Siebrecht is silent regarding a bipolar activation switch configured to provide electrical energy to both electrically conductive tissue sealing plates upon activation thereof and a monopolar activation switch configured to provide electrical energy to the electrode upon activation thereof.
However, Dumbauld teaches a control switch for bipolar activation and monopolar, where the bipolar mode is used for vessel sealing and the monopolar mode for dissection (par. [0127] and [0141]).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the switching bipolar and monopolar for sealing and cutting, as in Dumbauld, allowing for delivering the appropriate energy depending on the treatment desired.
Regarding claim 8, Siebrecht is silent regarding a bipolar activation switch configured to provide
electrical energy to both electrically conductive tissue sealing plates upon activation thereof and a monopolar activation switch configured to provide electrical energy to the electrode upon activation thereof, wherein the sensor disables power to the bipolar activation switch when the first and second jaw members are disposed in the open configuration.
However, Dumbauld teaches a control switch for bipolar activation and monopolar, where the bipolar mode is used for vessel sealing and the monopolar mode for dissection (par. [0127] and [0141]).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the switching bipolar and monopolar for sealing and cutting, as in Dumbauld, allowing for delivering the appropriate energy depending on the treatment desired.
Boudreaux teaches a closure sensor associated with the jaw member to sense when the jaws are open or closed (par. [0342] detect closure angle of jaw relative to body), and communicating with electrical energy source to configure the instrument for a mode of operation depending on activation (par. [0342] control module in communication with sensor to select operation).
It would have been obvious to one of ordinary skill in the art to restrict activation of electrosurgical energy depending on the jaw position, to prevent undesired energy delivery when there is no tissue to be treated.
Regarding claim 9, Siebrecht teaches an end effector assembly for an electrosurgical instrument, comprising:
a pair of opposing first and second jaw members each including a jaw housing supporting an electrically conductive tissue sealing plate disposed thereon (jaw members 110 with jaw housings 114 and 124 and sealing plates 112 and 122), the electrically conductive tissue sealing plates of the first and second jaw members disposed in opposition relative to one another (at least Fig. 3), at least one of the first or second jaw member movable relative to the other jaw member to grasp tissue therebetween (at least par. [0043] tissue grasped between the jaw members), the electrically conductive tissue sealing plates of the first and second jaw members adapted to connect to opposite potentials of an electrosurgical energy source (par. [0034] bipolar from generator), the electrically conductive tissue sealing plates of the first and second jaw member each having an open T-shaped configuration defining a channel along a length thereof (par. [0012] T-shaped channel), a blade disposed within the channel of the electrically conductive tissue sealing plate of the first jaw member and extending to a distal end portion thereof (blade 190 within channel as in par. [0046] and extending distally), and an insulative member is disposed within the channel of the electrically conductive tissue sealing plate of the second jaw member in opposing vertical registration to the plasma blade (119' and 129' as in par. [0053] in opposition to the blade).
Siebrecht is silent regarding an electrode fixed within the channel, the blade as a plasma blade, the plasma blade electrically connected to the energy source and independently activatable from the electrically conductive tissue sealing plates. However, Mayer teaches using a cutting edge that can be a RF electrode that creates a plasma for cutting tissue (Figs. 9a-c and par. [0039] with a cutting element with electrically insulating material on either side of a cutting electrode 26), and the cutting element fixed in a channel of the jaw (at least Fig. 9a).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the blade as an electrode with insulated material as in Mayer, as a known energy delivery mechanism for the knife that would work to cut tissue grasped by jaws. It would have further been obvious to modify Siebrecht with the cutting element fixed in the channel, as a way to deliver cutting energy while reducing the number of mechanisms in the device.
Regarding claim 10, Siebrecht teaches the blade including an insulative material on either side thereof configured to focus electrical and thermal energy to an exposed edge defined along a length of the blade (insulative substrate 129' as in Fig. 7a and par. [0045]).
Mayer teaches the electrode as in claim 9.
Regarding claim 14, Siebrecht is silent regarding a sensor operably associated with at least one of the first and second jaw members and configured to sense when the first and second jaw members are disposed in an open configuration, the sensor communicating with the electrical energy source to configure the electrosurgical instrument for monopolar use upon activation thereof.
However, Boudreaux teaches a closure sensor associated with the jaw member to sense when the jaws are open or closed (par. [0342] detect closure angle of jaw relative to body), and communicating with electrical energy source to configure the instrument for a mode of operation depending on activation (par. [0342] control module in communication with sensor to select operation).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the sensor of Boudreaux to activate treatment depending on if tissues are grasped by the jaws.
Regarding claim 15, Siebrecht is silent regarding a bipolar activation switch configured to provide electrical energy to both electrically conductive tissue sealing plates upon activation thereof and a monopolar activation switch configured to provide electrical energy to the electrode upon activation thereof.
However, Dumbauld teaches a control switch for bipolar activation and monopolar, where the bipolar mode is used for vessel sealing and the monopolar mode for dissection (par. [0127] and [0141]).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the switching bipolar and monopolar for sealing and cutting, as in Dumbauld, allowing for delivering the appropriate energy depending on the treatment desired.
Regarding claim 16, Siebrecht is silent regarding a bipolar activation switch configured to provide electrical energy to both electrically conductive tissue sealing plates upon activation thereof and a monopolar activation switch configured to provide electrical energy to the electrode upon activation thereof, wherein the sensor disables power to the bipolar activation switch when the first and second jaw members are disposed in the open configuration.
However, Dumbauld teaches a control switch for bipolar activation and monopolar, where the bipolar mode is used for vessel sealing and the monopolar mode for dissection (par. [0127] and [0141]).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the switching bipolar and monopolar for sealing and cutting, as in Dumbauld, allowing for delivering the appropriate energy depending on the treatment desired.
Boudreaux teaches a closure sensor associated with the jaw member to sense when the jaws are open or closed (par. [0342] detect closure angle of jaw relative to body), and communicating with electrical energy source to configure the instrument for a mode of operation depending on activation (par. [0342] control module in communication with sensor to select operation). It would have been obvious to one of ordinary skill in the art to restrict activation of electrosurgical energy depending on the jaw position, to prevent undesired energy delivery when there is no tissue to be treated.
Claim(s) 3-4 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siebrecht in view of Mayer, in view of Shadduck (US 2013/0090642).
Regarding claim 3, Siebrecht is silent regarding the insulative member is made of a compliant high temperature silicone.
However, Shadduck teaches silicone as a known material that is an insulative material (par. [0039]).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the insulative material made of silicone, as in Shadduck, allowing for an insulative material that would be bio-compatible (par. [0039]).
Regarding claim 4, Siebrecht is silent regarding the insulative member is selected from the group consisting of ceramic, parylene, nylon, and PTFE.
However, Shadduck teaches PTFE as a known material that is an insulative material (par. [0039]).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the insulative material made of PTFE, as in Shadduck, allowing for an insulative material that would be bio-compatible (par. [0039]).
Regarding claim 11, Siebrecht is silent regarding the insulative member is made of a compliant high temperature silicone.
However, Shadduck teaches silicone as a known material that is an insulative material (par. [0039]).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the insulative material made of silicone, as in Shadduck, allowing for an insulative material that would be bio-compatible (par. [0039]).
Regarding claim 12, Siebrecht is silent regarding the insulative member is selected from the group consisting of ceramic, parylene, nylon, and PTFE.However, Shadduck teaches PTFE as a known material that is an insulative material (par. [0039]).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the insulative material made of PTFE, as in Shadduck, allowing for an insulative material that would be bio-compatible (par. [0039]).
Claim(s) 5 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siebrecht in view of Mayer, in view of Reschke (US 2011/0046623).
Regarding claim 5, Siebrecht is silent regarding a bridge disposed within the first jaw member at a proximal end thereof, the bridge configured to provide electrical continuity across the electrically conductive tissue sealing plates of the first and second jaw members.
However, Reschke teaches a bridge in a jaw member at a proximal end thereof (portion of 312 at the proximal end of the jaw connecting the left and the right portions of the jaw as in Fig. 3a).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the bridge of Reschke, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Furthermore, it appears that the invention would perform equally well with moving the bridge proximally in the jaw.
Regarding claim 13, Siebrecht is silent regarding a bridge disposed within the first jaw member at a proximal end thereof, the bridge configured to provide electrical continuity across the electrically conductive tissue sealing plates of the first and second jaw members.
However, Reschke teaches a bridge in a jaw member at a proximal end thereof (portion of 312 at the proximal end of the jaw connecting the left and the right portions of the jaw as in Fig. 3a).
It would have been obvious to one of ordinary skill in the art to modify Siebrecht with the bridge of Reschke, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Furthermore, it appears that the invention would perform equally well with moving the bridge proximally in the jaw.
Response to Arguments
Applicant's arguments filed 3/30/26 have been fully considered but they are not persuasive. Applicant argues that one of ordinary skill in the art would not modify Siebrecht with Mayer given Siebrecht does not have an electric device. However, in modifying Siebrecht with the cutting electrode of Mayer, one would want to use insulation.
Applicant further argues that one of ordinary skill in the art would not modify the mechanical cutting of Siebrecht with the electrical cutting of Mayer. However, using both mechanical and electrical provides benefits known to one of ordinary skill in the art including reducing blood loss.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Reschke (US 2014/0194875) teaches a fixed cutting electrode in a jaw.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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