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 (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.
Response to Amendment
Claims 1, 3, 4, 7, 9, 10, 12, and 17-19 are amended, claims 2, 5, 6, 13-15, and 20 are cancelled. Claims 21-27 are newly added. Claims 1, 3-4, 7-12, 16-19, and 21-27 are pending herein.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/10/2026, with respect to the rejection(s) of claim(s) 17-20 under 35 U.S.C. 102(a)(1) as being anticipated by Long (US 2011/0098704) have been fully considered and are persuasive. The amended limitations including the first electrode “fixed to the shaft assembly” and second electrode configured to “translate within the working lumen of the shaft assembly” are not taught by Long. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rioux (US 2005/0234443).
Applicant’s arguments, see Remarks, filed 06/10/2026, with respect to the rejection(s) of claim(s) 1-7 and 16 under 35 U.S.C. 103 as being unpatentable over Ostrovsky (US 2009/0118728) have been fully considered and are persuasive. The amended limitations are not taught. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rioux (US 2005/0234443).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-4, 7, 16, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky (US Patent Publication 2009/0118728), herein after “Ostrovsky”, in view of Rioux (US 2005/0234443), herein after “Rioux”.
Regarding claims 1 and 27, Ostrovsky teaches the “a method”, “(c) placing the first electrode of the variable distance electrode assembly adjacent to a targeted tissue”, “(d) placing the second electrode of the variable distance electrode assembly adjacent to the targeted tissue area such that the first electrode and the second electrode are spaced from each other to define a first distance”, “(e) activating the first electrode and the second electrode to apply electrical energy to the targeted tissue area” in the Abstract, which states “A method of ablating a tissue comprises inserting first and second electrodes to desired initial positions relative to a tissue mass to be ablated and applying electrical energy to the first and second electrodes to ablate a first portion of tissue between the first and second electrodes in combination with the step of applying electrical energy to desired second positions separated from the desired initial positions by a distance selected to transfer electrical energy around the first portion of tissue through a second portion of tissue to be ablated, the second portion of tissue surrounding the first portion of tissue."
Ostrovsky does not explicitly teach “inserting a variable distance electrode assembly within a patient”, “(b) moving an actuatable body having a first electrode coupled thereto within a shaft assembly having a second electrode coupled thereto such that the first electrode moves from a first position interior to the shaft assembly to a second position distal to the second electrode and the shaft assembly” and “(f) translating the actuatable body and the first electrode relative to the second electrode to define a second distance between each other while the first electrode and the second electrode continue to apply electrical energy to the targeted tissue area” or the limitation from claim 27, “wherein translating the actuatable body includes maintaining contact between the targeted tissue area and each of the first electrode and the second electrode”, but Rioux does in an analogous ablation probe. Rioux teaches “inserting a variable distance electrode assembly within a patient (p.[0043], Fig. 8A)”, “(b) moving an actuatable body having a first electrode coupled thereto within a shaft assembly (Fig. 4, shaft 136, electrode 150) having a second electrode coupled thereto (126), such that the first electrode moves from a first position interior to the shaft assembly to a second position distal to the second electrode and the shaft assembly (Fig. 4, p.[0046])”, and “(f) translating the actuatable body and the first electrode relative to the second electrode to define a second distance between each other while the first electrode and the second electrode continue to apply electrical energy to the targeted tissue area (p.[0046])”, “wherein translating the actuatable body includes maintaining contact between the targeted tissue area and each of the first electrode and the second electrode (p.[0046])”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Rioux in Ostrovsky. The use of the actuatable body produces predictable results of reducing the risk of ablating healthy tissue by adjusting the distance between electrodes to more accurately treat the desired tissue.
Regarding claim 3, the limitations of claim 2 are taught as described above. Ostrovsky teaches “the second electrode is fixed to the shaft assembly” in Figure 11-12 shows electrode 104 on the shaft assembly and therefore teaches the limitation as described.
Regarding claim 4, the limitations of claim 3 are taught as described above. Ostrovsky teaches “the second electrode is annular shaped and fixed to an open distal end of the shaft assembly” in Figure 11, which shows that the electrode is fixed to an “open” (wherein the Examiner interprets open to mean it is not enclosed by another structure) distal end of the shaft assembly. Ostrovsky does not explicitly teach that the electrode is annular shaped, however, Ostrovsky does state “Since the distance between the electrodes and the size and shape of the electrodes may be specified, damage to nearby organs can be minimized” (p.[0069]). It is the Examiner’s position that because Ostrovsky contemplates that the shape of the electrode can be changed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ostrovsky into an annular-shaped electrode. As stated in Ostrovsky, different electrode shapes can be chosen to minimize damage to nearby organs, and produces predictable results. Moreover, since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See In re Dailey, 149 USPQ 47 (CCPA 1976). It appears that the disclosed device would perform equally well shaped as disclosed by Ostrovsky.
Regarding claim 7, the limitations of claim 1 are taught as described above. Ostrovsky teaches the limitation “further comprising directly contacting at least one of the first electrode and the second electrode against the targeted tissue area while translating the actuatable body at the first electrode relative to the second electrode to define the second distance” in p.[0057] which states "Alternatively, pneumatic or hydraulic power may be used to achieve or control the movement of the electrodes 102, 104 as they are displaced to compress selected portions of the target tissue mass 150. In different embodiments, piezoelectric actuators or other electric actuators may be utilized to move the electrodes 102, 104 relative to one another and to provide and maintain the desired tissue compression." It is the Examiner's position that the first or second electrode directly contacts or otherwise contacts the targeted tissue area while the second or first electrode could also be translated simultaneously to define a distance to maintain the desired tissue compression in the procedure, and such a procedure produces predictable results of treating targeted tissue while avoiding treating healthy tissue.
Regarding claim 16, the limitations of claim 1 are taught as described above. Ostrovsky teaches “further comprising applying RF energy to ablate the targeted tissue area while activating the first electrode and the second electrode” in the abstract, which states “Abstract "A method of ablating a tissue comprises inserting first and second electrodes to desired initial positions relative to a tissue mass to be ablated and applying electrical energy to the first and second electrodes to ablate a first portion of tissue between the first and second electrodes in combination with the step of applying electrical energy to desired second positions separated from the desired initial positions by a distance selected to transfer electrical energy around the first portion of tissue through a second portion of tissue to be ablated, the second portion of tissue surrounding the first portion of tissue." Note that electrical energy encompasses RF energy, and therefore teaches the limitation as described.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky and Rioux in view of Townley (US Patent Publication 2022/0079656) herein after “Townley”.
Regarding claim 8, the limitations of claim 1 are taught as described above. Ostrovsky/Rioux does not “comprising communicating a fluid to the targeted tissue area”, but Townley does in an analogous electrosurgical device. Townley teaches in p.[0151] " The handheld device 102 may further include an auxiliary line 121, which may provide a fluid connection between a fluid source, for example, and the shaft 116 such that fluid may be provided to a target site via the distal end of the shaft 116". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Townley in view of Ostrovsky/Rioux. It is known in the art to use irrigation or fluid delivery in electrosurgical devices to either remove debris from ablation, cool treated tissue from ablation, or otherwise deliver therapeutic agents to a treatment site, all of which produce predictable results known in the art as described above.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky, Rioux, in view of Townley and Salahieh (US Patent Publication 2017/0080184), herein after “Salahieh”.
Regarding claim 9, the limitations of claim 8 are taught as described above. Ostrovsky/Rioux/Townley does not teach the claimed limitation “further comprising sliding a fluid delivery member toward the targeted tissue area”, but Salahieh does in an analogous tissue treatment device. Salahieh teaches this limitation in p.[0063] which states " Handle 11 includes at least one delivery member actuation element 12 (two shown), and at least one fluid control actuation element 15 (two shown). Delivery member actuation element 12 can be adapted to steer delivery member 13, including distal delivery region 14, to a target location within the body. Delivery member actuation element 12 can also be adapted to reconfigure distal delivery region 14 between a delivery configuration and one or more procedural configurations. Fluid control actuation element 15 is adapted to actuate fluid controls 16 to effect peripheral tissue remodeling." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Salahieh in Ostrovsky/Rioux/Townley. It is known in the art to use fluid as an irrigate to cool tissue after ablation and produces predictable results of reducing the energy/temperature of the tissue.
Regarding claim 10, the limitations of claim 9 are taught as described above. Ostrovsky/Townley/Rioux does not teach the claimed limitation “the fluid delivery member being slidably disposed within the shaft assembly, the method further comprising sliding the fluid delivery member distally past the shaft assembly while sliding the fluid delivery member toward the targeted tissue area” but Salahieh does in an analogous tissue treatment device. Salahieh teaches this limitation in p.[0065-0057], specifically "After the treatment has been administered, control member 33 is advanced distally with respect to the proximal portion of sheath 36 to move the ends of the tubular elements away from one another, reconfiguring the tubular elements back towards their delivery configurations. When the tubular elements are in their expanded configurations, ejection ports 35 are disposed in a plane substantially normal to that of the longitudinal axis of elongate delivery member 13" Note that the control member may also include the fluid delivery member. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Salahieh in view of Ostrovsky. It is known in the art to use fluid as an irrigate to cool tissue after ablation and produces predictable results of reducing the energy/temperature of the tissue.
Regarding claim 11, the limitations of claim 10 are taught as described above. Ostrovsky/Townley does not teach the claimed limitation, however, Salahieh does in an analogous tissue treatment device. Salahieh teaches this limitation in p.[0088] which states "In yet another embodiment as depicted in FIG. 38, a penetrating remodeling element 19 is a needle. The needle has a helical configuration and delivered while contained with an outer sheath of a delivery section 13 of a delivery system, not shown. In this configuration, the outer sheath of the delivery section has a stiffness sufficient to maintain the spring element in a straightened configuration. On delivery the remodeling element is pushed distally out of the distal end of the outer sheath of the delivery system until the distal end of the remodeling element has passed into the vessel wall. The remodeling element is then twisted, which in combination with the pre-set spiral configuration allows the remodeling element 16 to screw its way around the vessel within the adventitial layer." Note that adventitial tissue constitutes as a targeted tissue area. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Salahieh in Ostrovsky/Rioux/Townley. As stated in Salahieh, the use of the needle allows for greater penetration of the fluid as desired during the procedure and produces predictable results (p.[0088-0090]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky, Rioux, Townley, and Salahieh in view of Palushi (US 2022/0054188), herein after “Palushi”.
Regarding claim 12, the limitations of claim 10 are taught as described above. Neither Salahieh nor Ostrovsky nor Townley nor Rioux teach “further comprising delivering a conductive fluid to the targeted tissue area through the actuatable body”, but Palushi does in an analogous electrosurgical device. Palushi teaches in p.[0021, 0096-0097,0104] that a delivery cannula may be used to provide irrigation at the site, and the delivery cannula also includes loop electrodes (part of the actuatable body). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Palushi in view of Salahieh/Ostrovsky/Townley/Rioux. As stated in Palushi, doing so allows the device “to deliver therapeutic agent, loop electrode assembly (240) may be used to provide electroporation of tissue to thereby facilitate delivery of the therapeutic substances, etc. from cannula (260) to the tissue" and produces predictable results of delivering fluid to the tissue site.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Long in view of Rioux.
Regarding claim 17, Long teaches “(a) a shaft assembly (20) defining a working lumen (26,27, p.[0030]) and terminating into a distal open end”, “(b) a variable displacement electrode assembly (24, 25) configured to ablate tissue, comprising: (i) a first electrode (24)
Long does not teach “a first electrode fixed to the shaft assembly” and “… configured to translate within the working lumen of the shaft assembly”, but Rioux does in an analogous electrosurgical device. Rioux teaches “a first electrode fixed to the shaft assembly (Fig. 4, shaft 136, electrode 150)” and “… configured to translate within the working lumen of the shaft assembly (p.[0046])”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Rioux in Long. The use of the actuatable body produces predictable results of reducing the risk of ablating healthy tissue by adjusting the distance between electrodes to more accurately treat the desired tissue.
Regarding claim 18, the limitations of claim 17 are taught as described above. Long teaches “the second electrode (25) being attached to an actuatable body slidably contained within the shaft assembly (“The electrode 25 can be slideably moved in and out of the distal end of the second lumen 27 using a slide member 31 to retract and/or advance the second electrode 25.”, p.[0033])”, but does not teach “and the actuatable body is slidable such that the actuatable body extends out of the distal open end of the shaft assembly and the second electrode is distal to the first electrode”, but Rioux does in an analogous ablation probe. Rioux teaches “and the actuatable body is slidable such that the actuatable body extends out of the distal open end of the shaft assembly and the second electrode is distal to the first electrode (p.[0046])”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Rioux in Long. The use of the actuatable body produces predictable results of reducing the risk of ablating healthy tissue by adjusting the distance between electrodes to more accurately treat the desired tissue.
Regarding claim 19, the limitations of claim 18 are taught as described above. Long teaches “further comprising a handle assembly, the handle assembly comprising: (a) a body, (b) a first slider, slidably attached to the body and operatively engaged with the actuatable body to cause movement of the actuatable body (p.[0033], “In one embodiment, the first and second electrical conductors 18, 19 may be provided through the handle 28. In the illustrated embodiment, the electrode 24 can be slidably moved in and out of the distal end of the first lumen 26 using a slide member 30 to retract and/or advance the first electrode 24. The electrode 25 can be slidably moved in and out of the distal end of the second lumen 27 using a slide member 31 to retract and/or advance the second electrode 25. In various embodiments either or both electrodes 24, 25 may be coupled to a single slide member, or additional slide members, to advance and retract the electrodes 24, 25, e.g., position the electrodes 24, 25. In the illustrated embodiment, the first electrical conductor 18 coupled to the first electrode 24 is coupled to the slide member 30. In this manner, the first electrode 24, which is slidably movable within the cannula, lumen, or channel defined by the first lumen 26, can be advanced and retracted with the slide member 30. In the illustrated embodiment, the second electrical conductor 19 coupled to the second electrode 25 is coupled to the slide member 31. In this manner, the second electrode 25, which is slidably movable within the cannula, lumen, or channel defined by the second lumen 27, can be advanced and retracted with the slide member 31. In one embodiment, various slide members, such as the slide member 31, are rotatable. Thus rotation of the slide member 30, 31 rotates the corresponding electrode 24, 25, respectively, at the distal end of the electrical ablation device 20.”)”.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Long in view of Ostrovsky and Salahieh.
Regarding claim 21, the limitations of claim 17 are taught as described above. Long does not teach “wherein the first electrode is fixed to a distal end of the shaft assembly” and “the apparatus includes a fluid delivery member slidably disposed within the shaft assembly to be located distal to the first and second electrodes”, but Ostrovsky and Rioux does. Ostrovsky teaches “wherein the first electrode is fixed to a distal end of the shaft assembly (Fig. 11-12)” in an analogous ablation device, and Salahieh teaches “the apparatus includes a fluid delivery member slidably disposed within the shaft assembly to be located distal to the first and second electrodes” in an analogous tissue treatment device. Salahieh teaches this limitation in p.[0063] in an analogous electrosurgical device which states “Handle 11 includes at least one delivery member actuation element 12 (two shown), and at least one fluid control actuation element 15 (two shown). Delivery member actuation element 12 can be adapted to steer delivery member 13, including distal delivery region 14, to a target location within the body. Delivery member actuation element 12 can also be adapted to reconfigure distal delivery region 14 between a delivery configuration and one or more procedural configurations. Fluid control actuation element 15 is adapted to actuate fluid controls 16 to effect peripheral tissue remodeling." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Salahieh in Ostrovsky/Long. It is known in the art to use fluid as an irrigate to cool tissue after ablation and produces predictable results of reducing the energy/temperature of the tissue.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Long, Rioux, and Salahieh.
Regarding claim 22, the limitations of claim 19 are taught as described above. Neither Long nor Rioux teaches “wherein the handle assembly further includes a second slider slidably attached to the body and operatively engaged with a fluid delivery member to cause movement of the fluid delivery member within the shaft assembly”, but Salahieh does in an analogous electrosurgical device. Salahieh teaches this limitation in p.[0063] which states “Handle 11 includes at least one delivery member actuation element 12 (two shown), and at least one fluid control actuation element 15 (two shown). Delivery member actuation element 12 can be adapted to steer delivery member 13, including distal delivery region 14, to a target location within the body. Delivery member actuation element 12 can also be adapted to reconfigure distal delivery region 14 between a delivery configuration and one or more procedural configurations. Fluid control actuation element 15 is adapted to actuate fluid controls 16 to effect peripheral tissue remodeling." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Salahieh in Long/Rioux. It is known in the art to use fluid as an irrigate to cool tissue after ablation and produces predictable results of reducing the energy/temperature of the tissue.
Claims 23 and 25-26 are rejected under 35 U.S.C 103 as being unpatentable over Ostrovsky in view of Rioux in view of Salahieh.
Regarding claims 23 and 25-26, the limitations of claim 1 are taught as described above. Ostrovsky/Rioux does not teach “prior to moving the actuatable body, sliding a fluid delivery member through the shaft assembly and toward the targeted tissue area such that a distal end of the fluid delivery member is positioned distal to the shaft assembly, the first electrode and the second electrode”, or “wherein sliding the fluid delivery member includes sliding a first slider operably coupled to the fluid delivery member” or “wherein moving the actuatable body and translating the actuatable body includes sliding a second slider operably coupled to the actuatable body” but Salahieh does in an analogous electrosurgical device. Salahieh teaches this limitation in p.[0063] which states “Handle 11 includes at least one delivery member actuation element 12 (two shown), and at least one fluid control actuation element 15 (two shown). Delivery member actuation element 12 can be adapted to steer delivery member 13, including distal delivery region 14, to a target location within the body. Delivery member actuation element 12 can also be adapted to reconfigure distal delivery region 14 between a delivery configuration and one or more procedural configurations. Fluid control actuation element 15 is adapted to actuate fluid controls 16 to effect peripheral tissue remodeling." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Salahieh in Long/Rioux. It is known in the art to use fluid as an irrigate to cool tissue after ablation and produces predictable results of reducing the energy/temperature of the tissue.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky, Rioux, and Salahieh in view of Palushi.
Regarding claim 24, the limitations of claim 23 are taught as described above. Neither Ostrovsky, Rioux, nor Salahieh teach “prior to moving the actuatable body and after sliding the fluid delivery member, delivering a conductive fluid to the targeted tissue area through the fluid delivery member”, but Palushi does in an analogous electrosurgical device. Palushi teaches in p.[0021, 0096-0097,0104] that a delivery cannula may be used to provide irrigation (saline, a conductive fluid) at the site before or after moving the device, and the delivery cannula also includes loop electrodes (part of the actuatable body). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Palushi in view of Salahieh/Ostrovsky/Rioux. As stated in Palushi, doing so allows the device “to deliver therapeutic agent, loop electrode assembly (240) may be used to provide electroporation of tissue to thereby facilitate delivery of the therapeutic substances, etc. from cannula (260) to the tissue" and produces predictable results of delivering fluid to the tissue site.
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 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 Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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