DETAILED ACTION
Applicant's amendments and remarks, filed 7/7/25, are fully acknowledged by the Examiner. Currently, claims 1-18 are pending with claims 1 and 9 amended. Applicant's amendment to claim 9 has overcome the previously filed 35 USC 112(b) rejection. The following is a complete response to the 7/7/25 communication.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6, 10-11, and 14-18 is/are rejected under pre-AIA 35 U.S.C. 103{a) as being unpatentable over Auth (US 6,030,380) in view of Manzo (US 2006/0079884), in view of Gondo (2004/0181213).
Regarding claim 1, Auth teaches an electrosurgical device for creating a channel through a region of tissue using energy provided by an electrical energy source, the electrosurgical device comprising: an elongate member which is an inner electrical conductor (50) for receiving the energy form the electrical energy source ; an electrode tip provided at the distal end of the elongate member for delivery of the energy to the region of tissue (electrode tip 48 connected to distal end of 50), the electrode tip being electrically coupled to the elongate member (electrode 48 coupled to 50 as in col. 3, lines 18- 30 and at least Fig. 3); An insulation layer which is a first electrically insulating material surrounding the elongate member (insulation 54). Auth is silent regarding a second insulation layer which is a second electrically insulating material, the
first insulation layer and the second insulation layer surrounding the elongate member, the second insulation layer distal to the first insulation layer, wherein the first insulation layer overlaps the second insulation layer.
However, Manzo teaches an electrosurgical device with inner and outer insulation surrounding a wire as in at least Fig. 6d and par. [0045], the outer layer overlapping the inner layer (78 over 76 as in par. [0045]).
It would have been obvious to one of ordinary skill in the art to modify Auth with the multiple layers of insulation as in Manzo, to prevent capacitive leakage (par. [0045]).
Auth is further silent regarding an electrically insulative thermal shield disposed between a proximal end of the electrode tip and the first insulation layer for thermally protecting the first insulation layer from heat produced by the delivery of the energy through the electrode tip, and the second insulation layer surrounds the elongate member inside of the electrically insulative thermal shield, and wherein the first insulation layer is positioned proximally to the electrically insulative thermal shield.
Gondo teaches an electrically insulative thermal shield disposed between a proximal end of an electrode tip and the electrical insulation for thermally protecting the electrical insulation from heat produced by the delivery of the energy through the electrode tip (heat resisting tube 15 as in par. [0035]).
It would have been obvious to one of ordinary skill in the art to modify Auth with the thermal shield of Gondo, so as to prevent the core to be exposed to high temperatures from the electrode as in par. [0039]. One of ordinary skill in the art would appreciate that the insulation would be proximal to the thermal shield as in at least Fig. 2 of Gondo, as a way to protect the core wire with the thermal shield.
Regarding claim 2, Auth is not explicit regarding a proximal portion of the second insulation layer is proximal of the electrically insulative thermal shield and underlapping a distal end of the first insulation layer.
Manzo teaches the second insulation layer under a first insulation layer as in at least Fig. 6d and par. [0045].
Gondo teaches the thermal shield (heat resisting tube 15, with insulative layer 16 adjacent to and contacting 15).
It would have been obvious to one of ordinary skill in the art that in the combination, the second layer of Manzo would be proximal of the thermal shield of Gonzo, and under the first insulation layer.
Regarding claim 3, Auth is silent regarding the thermal shield.
However, Gondo teaches the electrically insulative thermal shield, with a first insulation layer distal end adjacent to and contacting the thermal shield (heat resisting tube 15, with insulative layer 16 adjacent to and contacting 15).
It would have been obvious to one of ordinary skill in the art to modify Auth with the thermal shield of Gondo, so as to prevent the core to be exposed to high temperatures from the electrode as in par. [0039].
Regarding claim 6, Auth teaches the first electrically insulating material comprises a polytetrafluoroethylene (col. 2, lines 8-9).
Regarding claim 10, Auth is silent regarding the thermal shield.
However, Gondo teaches the thermal shield is a ceramic thermal shield (par. [0035]).It would have been obvious to one of ordinary skill in the art to modify Auth with the thermal shield of Gondo, so as to prevent the core to be exposed to high temperatures from the electrode as in par. [0039].
Regarding claim 11, Auth is silent regarding the thermal shield.
Gondo teaches wherein the thermal shield is tubular (at least Fig. 1).
This would allow for the thermal shield to circumferentially surround the wire, in order to thermally insulate the core wire.
Regarding claim 14, Auth teaches the elongate member is a core wire (50).
Regarding claim 15, Auth is not explicit regarding the elongate member is a hypotube. However, Manzo teaches elongate members for electrical conduction as a hypotube (70, 72).
It would have been obvious to one of ordinary skill in the art to modify Auth with the elongate member as a hypotube as in Manzo, as a known element allowing for electrical conductivity in the same manner as Auth.
Regarding claim 16, Auth teaches the elongate material is comprised of Nitinol (col. 3, lines 25- 28; 50 made of nitinol).
Regarding claim 17, Auth teaches the electrode tip as rounded (48 rounded as in at least Fig. 3).
Regarding claim 18, Auth is silent wherein the outer diameter of the electrode tip is substantially equal to the outer diameter of the electrically insulative thermal shield.
Gondo teaches an electrically insulative thermal shield disposed between a proximal end of an electrode tip and the electrical insulation for thermally protecting the electrical insulation from heat produced by the delivery of the energy through the electrode tip (heat resisting tube 15 as in par. [0035]).
It would have been obvious to one of ordinary skill in the art to modify Auth with the thermal shield of Gondo, so as to prevent the core to be exposed to high temperatures from the electrode as in par. [0039].
Claims 4-5 are rejected under pre-AIA 35 U.S.C. 103{a) as being unpatentable over Auth in view of Manzo, in view of Gondo, in further view of West (US 5,318,525).
Regarding claim 4, Auth is silent regarding a support structure for supporting the electrode tip, the support structure having a proximal end, wherein the proximal end of the support structure is positioned distally with respect to a distal end of the electrically insulative thermal shield.
However, West teaches a support structure (anchor plate 72) supporting an electrode tip (20) as in col. 7, lines 1-3.
It would have been obvious to one of ordinary skill in the art to modify the combination with the support structure of West, so as to electrically isolate the electrode tip from the rest of the device.
Regarding claim 5, Auth is silent regarding the support structure.
However, West teaches the proximal end of the support structure is positioned distally with respect to a distal end of the second insulation layer.
Claim 7-8 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Auth in view of Manzo, in view of Gondo, in view of Littman (US 5,509,411).
Regarding claim 7, Auth is not explicit regarding the second insulating material comprises a polyimide.
However, Littman teaches polyimide as a material as an insulative layer (col. 8, lines 62-68).
It would have been obvious to one of ordinary skill in the art to modify the combination with polyimide as an insulating material as in Littman, to minimize cross talk (col. 8, lines 62-68).
Regarding claim 8, Auth teaches the first electrically insulating material comprises a polytetrafluoroethylene (col. 2, lines 8-9), but is not explicit regarding the second insulating material comprises a polyimide.
However, Littman teaches polyimide as a material as an insulative layer (col. 8, lines 62-68).
It would have been obvious to one of ordinary skill in the art to modify the combination with polyimide as an insulating material as in Littman, to minimize cross talk (col. 8, lines 62-68).
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Auth in view of Manzo, in view of Gondo, in view of Davies (US 2007/0123964).
Regarding claim 9, Auth is not explicit wherein the second insulation layer is substantially thinner than the first insulation layer.
Manzo teaches the layers as above.
Davies teaches an electrosurgical instrument with two insulating insulators, one thinner than another (par. [0047]).
It would have been obvious to one of ordinary skill in the art to modify Auth with the multiple layers of insulation with different thicknesses, as in Davies, being sufficiently insulating, while providing flexibility or other desired material properties such as lubriciousness (par. [0047]).
Claims 12-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Auth in view of Manzo, in view of Gondo, in further view of Roschak (US 2002/0087153).
Regarding claim 12, Auth does not teach the thermal shield.
Roschak teaches insulating surfaces as PTFE (par. [0074)).
It would have been obvious to one of ordinary skill in the art to modify the thermal shield to be zirconia oxide, as a known material that would work as an insulator.
Regarding claim 13, Auth does not teach the thermal shield. Gondo teaches the thermal shield as above. Roschak teaches insulating surfaces as zirconia oxide (par. [0074]). It would have been obvious to one of ordinary skill in the art to modify the thermal shield to be zirconia oxide, as a specific ceramic that would work as an insulator.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection |.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying- online/eterminal-disclaimer.
Claims 1, 4, 6-8, 10, 11, and 14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 11, 15, and 16 of U.S. Patent No. 11,234,761. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘761 patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim 1 is taught by patented claim 1.
Claim 4 is taught by patented claim 2.
Claim 6 is taught by patented claim 11.
Claim 7 is taught by patented claim 11.
Claim 8 is taught by patented claim 11.
Claim 10 is taught by patented claim 15.
Claim 11 is taught by patented claim 16.
Claim 14 is taught by patented claim 1.
Response to Arguments
Applicant's arguments filed 7/7/25 have been fully considered but they are not persuasive. Applicant argues that Manzo does not teach the insulation layers positioned relative to a thermal shield. Gonzo teaches the thermal shield, but applicant argues that Gonzo does not teach the thermal shield relative to the second insulation layer. However, Gonzo does teach the thermal shield with insulation (par. [0036] with coating layers 16 and 16a proximally to thermal shield 15). One of ordinary skill in the art would appreciate that the insulation would be proximal to the thermal shield as in at least Fig. 2 of Gondo, as a way to protect the core wire with the thermal shield.
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 BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794