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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24 July 2026 has been entered.
Claim Rejections - 35 USC § 102
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, 9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buckley et al. (US 2022/0226037).
Regarding claims 1 and 9, Buckley discloses an electrosurgical electrode (see Figs. 3-4B) comprising: a conductive rod including a distal end portion having a working portion (see knife 400 having a conductive rod having a distal working portion 425, Fig. 4A) and a proximal end portion configured to couple to an electrosurgical instrument (see proximal section 410 configured to couple to an electrosurgical instrument, Figs. 2 and 4A); and a non-conductive composite coating disposed on and fully covering an outer surface of the working portion (see multi-layered insulation material 400 fully covering an outer surface of the working portion directly underneath the multi-layered insulation material 400; [0068], Figs. 3-4B), the non-conductive composite coating including a first non-conductive coating formed from a first polymer disposed on the outer surface of the working portion (see first type of polymeric insulation material; [0068]) and a second non-conductive coating disposed over the first coating, the second coating formed from a second polymer, different from the first polymer (see second type of insulation material formed of a second type of polymeric material; [0068]), wherein the working portion is configured to connect to a source of electrosurgical energy for transmitting electrosurgical energy through the non-conductive composite coating to tissue (the working portion as disclosed by Buckley is configured to be connected to a source of electrosurgical energy that generates magnitudes of electrosurgical energy that would transmit an amount of electrosurgical energy through the multi-layered insulation material 400 by virtue of its proximal electrode end 410 as shown in Fig. 3 that can be connected to such a device).
Regarding claims 3 and 11, Buckley further discloses wherein the first coating includes polytetrafluoroethylene (see [0065]).
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 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Buckley in view of Miki et al. (US 2017/0290623).
Regarding claims 2 and 10, Buckley discloses the limitations of claims 1 and 9, however fails to further disclose wherein the outer surface of the working portion has a roughness from about 0.6 Ra to about 0.8 Ra.
Miki teaches an electrosurgical blade, wherein the base material of the blade is subjected to a blast treatment for form a pretreated portion having a surface roughness of 1 µm and ranging from 0.01 to 5 µm upon which a first layer is applied to (see [0036], see also Table 4). Therefore, it would have been obvious to one having ordinary skill in the art before the time of filing to modify the outer surface of working portion as disclosed by Buckley to have a roughness from about 0.6 Ra to about 0.8 Ra in light of Miki to provide the desired burning degree and adhesion properties to the applied coating, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Buckley in view of Ashley (US 6,176,857).
Regarding claims 4 and 12, Buckley discloses the limitations of claims 1 and 9, however fails to further disclose the non-conducive second coating is a powder coating of perfluoroalkoxy alkanes.
Ashley teaches an electrosurgical electrode (see Figs. 5A-5C) comprising an insulative coating (see thermal and electrical tip insulator 502) that includes fluoropolymers (e.g., the Teflon family, PTFE, FEP, PFA), silicones, polyamides (nylons), polyimides or ULTEM (see col. 9, lines 8-27). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first non-conductive coating to include perfluoroalkoxy alkanes in light of Ashley in order to provide the desired amount of thermal and electrical insulation, and further since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 4, Buckley in view of Ashley does not disclose powder coating specifically, however even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698; 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case, Buckley discloses the at least one layer of insulation material is applied via spray coating (see [0066]) which results in a coating that is materially the same.
Claims 5-7 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Buckley.
Regarding claims 5-7 and 13-15, Buckley further discloses the insulation layer as having a combined thickness of the single layer being approximately 100 microns (see [0064]) and also discloses that thicknesses may differ from its described range or be variable along its length (see [0065] and [0067]). Buckley fails to further disclose wherein the first coating has a thickness from about 7 µm to about 9 µm, wherein the second coating has a thickness from 12 µm to about 15 µm, or wherein the composite coating has a thickness from about 19 µm to about 24 µm.
However, it would have been obvious to one having ordinary skill in the art before the time of filing to modify the thickness of the second coating and composite coating such that the second coating has a thickness from 12 µm to about 15 µm and the composite coating has a thickness from about 19 µm to about 24 µm in light of Buckley dependent upon the material properties of the different polymer layers used and to provide the desired degree of electrical and thermal insulation from the applied coatings along the length of the working end of the device, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Buckley in view of McGreevy et al. (US 2008/0188845).
Regarding claims 8 and 16, Buckley discloses the limitations of claims 1 and 9, however fails to further disclose wherein the second coating has a roughness from about 0.2 Ra to about 0.4 Ra.
McGreevy teaches an electrosurgical device having an electrosurgical working surface for contacting tissue during tissue sealing, wherein the smoothness of the surface ranges from 0.15 to 0.40 Ra (see [0043]). Therefore, it would have been obvious to one having ordinary skill in the art before the time of filing to modify the roughness of the second coating to have a roughness from about 0.2 Ra to about 0.4 Ra in light of McGreevy to provide the desired amount of non-stick property to the outer surface of the blade, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
Response to Arguments
Applicant's arguments filed 24 July 2026 have been fully considered but they are not persuasive.
To the extent that applicant argues that Buckley fails to disclose the non-conductive composite coating disposed on and fully covering an outer surface of the working portion, the examiner respectfully disagrees. The examiner contends that the non-conductive composite coating does fully cover the surface upon which it is disposed. Applicant argues that the insulation 440 of Buckley does not provide for this feature since the insulation 440 is not disposed on exposed portion 435 of the working portion, however the examiner contends that since the claim employs the use of the transitional phrase “comprising” which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps such as the additional outer surfaces that a working portion can reasonably possess, such as an outer surface of the tip of the working portion. See MPEP 2111.03(I).
To the extent that applicant argues that Buckley fails to disclose “wherein the working portion is configured to connect to a source of electrosurgical energy for transmitting electrosurgical energy through the non-conductive composite coating to tissue”, the examiner respectfully disagrees. The examiner contends that the working portion is capable of performing the claimed functionality under the technical reasoning given in the updated rejection of claims 1 and 9 above. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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