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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 23rd, 2025 has been entered.
Response to Amendment
Applicant’s amendments to the claims have overcome the 112(b) rejections previously set forth in the Final Office Action mailed June 27th, 2025.
Response to Arguments
Applicant's arguments filed September 23rd, 2025 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments on pages 6-8 that Davison lacks two electrodes being on a same side face of the two side faces, the Examiner respectfully disagrees on the grounds that as defined, via merriamwebster.com, a face is “the front of something having two or four sides” such that the electrodes 906 and 908 are both disposed on the front side face as shown in the top/front view in Fig. 39B.
In response to applicant's arguments on pages 6-8 that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., language specifying that the electrodes are disposed on a same surface or plane, language specifying that the surface is a singular flat surface or language specifying that the electrodes both contact tissue when placed in contact with tissue) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, Applicant argues that “908 is not and cannot be at the upper face (as 906 is) in order for Davison to function as intended”, such that Applicant is reminded that no function has been claimed in claim 1 and/or claim 18 (see also: a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim). Since the function of the device or how it operates to treat tissue has not been described, there is not a structural difference between the claimed invention and Davison that indicates that the prior art structure is incapable of performing the same as the claimed invention.
Therefore, these arguments are not persuasive and the Examiner maintains that Davison discloses the claimed invention.
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.
Claims 1-3, 5-6, 12, 14 & 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Davison et al. (U.S. Pat. No. 8663216, previously cited), herein referred to as “Davison”.
Regarding claim 1, Davison discloses a high-frequency (HF) application system (electrosurgical system 5; Abstract: Systems and methods are provided for applying a high frequency voltage; Col. 41, lines 47-50: While the exemplary embodiment of the present invention has been described in detail, by way of example and for clarity of understanding, a variety of changes, adaptations, and modifications will be obvious to those of skill in the art) comprising:
at least one surgical HF instrument (electrosurgical probe 20/probe 900), which is equipped with a bipolar HF applicator (treatment member 910; wherein treatment member 910 comprises active electrode 906 and return electrode 908; see Fig. 39A and wherein this is a bipolar electrode configuration); and
an HF generator (power supply 10), which is designed to supply the bipolar HF applicator with HF energy (Col. 20, lines 19-20: power supply 10 for providing high frequency voltage),
wherein the bipolar HF applicator comprises:
a flat main body (electrode support 904) that is made of an insulating material (Col. 40, lines 14-16: The support may be made of an electrically non-conducting material such as, for example, ceramic), and has a rounded shape (Col. 40, lines 22-24: Support 904 has an annular or circular configuration and a cavity or recess 914 within a tissue contacting surface 912 for holding active electrode 906) with two side faces opposite each other (see Figs. 39A-39C to see two circular faces of treatment member 910 & are opposite each other) and an edge delimiting the two side faces (return electrode 908; wherein the return electrode is also the edge delimiting the two side faces; see Fig. 39C), the flat main body including, on a same side face of the two side faces, two electrodes (active electrode 906 & return electrode 908; wherein as defined, merriamwebster.com: face, “the front of something having two or four sides” such that the electrodes 906 and 908 are both disposed on the front side face as shown in the top/front view in Fig. 39B) including electrode surfaces that are isolated from each other on the same side face of the two side faces (Col. 40, lines 12-16: Support 904 supports an active electrode 906 and a return electrode 908 in a spaced apart relationship. The support may be made of an electrically non-conducting material such as, for example, ceramic; wherein the support 904 facilitates the electrical isolation),
wherein the two electrodes are connected or connectable via supply lines to two different output connectors of the HF generator (Col. 40, lines 16-21: active electrode 906 has ends 906a extending into and through openings in support structure 904 to a power supply via one or more conducting members (not shown). Return electrode 908 is operatively connected to the power supply via one or more conducting members (not shown)).
but Davison does not specifically teach wherein the flat main body with the two electrodes is designed to be flexibly bendable.
However, the particular flexibly bendable design used for the flat main body presents no novel or unexpected result over the ceramic material taught by Davison. Choosing a specific material solves no stated problem and would be an obvious matter of design choice within the skill of the art. In re Launder, 42 CCPA 886, 222 F.2d 371, 105 USPQ 446 (1955); Flour City Architectural Metals v. Alpana Aluminum Products, Inc., 454 F. 2d 98, 172 USPQ 341 (8th Cir. 1972); National Connector Corp. v. Malco Manufacturing Co., 392 F.2d 766. 157 USPQ 401 (8th Cir.) cert. denied, 393 U.S. 923, 159 USPQ 799 (1968).
Additionally, the instant application teaches that the material used does not produce an unexpected result, as it would be expected that different materials would enable different material properties based on desired probe characteristics, as demonstrated in paragraph [0016] of the instant application: “Suitable materials for the main body are, for example, plastics, ceramics, or silicones, the temperature stability of which is sufficient for the temperatures occurring during HF surgical procedures. Typical temperatures are approximately 80° C., so that a temperature stability of approx. 100° C. or above is favorable. Silicones, as well as soft plastics, are particularly suitable for flexible HF applicators due to their softness while ceramics and harder plastics can be used for more rigid HF applicators”.
Regarding claim 2, Davison discloses wherein the flat main body has a circular or elliptical shape (Col. 40, lines 22-24: Support 904 has an annular or circular configuration and a cavity or recess 914 within a tissue contacting surface 912 for holding active electrode 906).
Regarding claim 3, Davison discloses wherein the supply lines run inside the flat main body and emerge at the edge of the flat main body (Col. 40, lines 16-21: active electrode 906 has ends 906a extending into and through openings in support structure 904 to a power supply via one or more conducting members (not shown). Return electrode 908 is operatively connected to the power supply via one or more conducting members (not shown)).
Regarding claim 5, Davison discloses wherein: the two electrodes are circular, annular, or elliptical, (Col. 40, lines 27-28: active electrode 906 an annular, loop, ring or circular configuration; lines 57-58: return electrode 906 has a clip or loop configuration) and the two electrodes include an outer electrode and an inner electrode that is disposed inside the outer electrode (Col. 40, lines 51-54: Return electrode 908 is provided about the perimeter, circumference or outer surface of support 904 such that support 904 is partially positioned or extends between active electrode 906 and return electrode 908).
Regarding claim 6, Davison discloses wherein the inner electrode and the outer electrode are annular (Col. 40, lines 27-28: active electrode 906 an annular, loop, ring or circular configuration; lines 57-58: return electrode 906 has a clip or loop configuration), and the inner electrode is disposed concentrically inside the outer electrode (Col. 40, lines 51-54: Return electrode 908 is provided about the perimeter, circumference or outer surface of support 904 such that support 904 is partially positioned or extends between active electrode 906 and return electrode 908).
Regarding claim 12, Davison discloses wherein the flat main body comprises a channel structure for a fluid coolant, the channel structure being configured to receive the fluid coolant into the flat main body from outside and discharge the fluid coolant from the flat main body (Col. 41, lines 13-18: support 904 include one or more cut-out or recessed regions 917 and one or more openings or apertures 918. More particularly, the tissue-contacting surface 912 is recessed in one or more locations 917 to facilitate fluid flow within cavity 914 and contact with active electrode 906; lines 24-26: Aperture 918 further facilitates fluid circulation about active electrode 906 to increase conductivity in the contacted tissue area).
Regarding claim 14, Davison discloses wherein the flat main body has a circular or oval shape (Col. 40, lines 22-24: Support 904 has an annular or circular configuration and a cavity or recess 914 within a tissue contacting surface 912 for holding active electrode 906), and the channel structure has one or more circular or oval channels (Col. 41, lines 24-26: Aperture 918 further facilitates fluid circulation about active electrode 906 to increase conductivity in the contacted tissue area).
Regarding claim 18, Davison discloses a high-frequency (HF) application system (electrosurgical system 5; Abstract: Systems and methods are provided for applying a high frequency voltage; Col. 41, lines 47-50: While the exemplary embodiment of the present invention has been described in detail, by way of example and for clarity of understanding, a variety of changes, adaptations, and modifications will be obvious to those of skill in the art) comprising:
at least one surgical HF instrument (electrosurgical probe 20/probe 900), which is equipped with a bipolar HF applicator (treatment member 910; wherein treatment member 910 comprises active electrode 906 and return electrode 908; see Fig. 39A and wherein this is a bipolar electrode configuration); and
an HF generator (power supply 10), which is designed to supply the bipolar HF applicator with HF energy (Col. 20, lines 19-20: power supply 10 for providing high frequency voltage),
wherein the bipolar HF applicator comprises:
a flat main body (electrode support 904) that is made of an insulating material (Col. 40, lines 14-16: The support may be made of an electrically non-conducting material such as, for example, ceramic), and includes two side faces that have a round or elliptical shape and are opposite each other (Col. 40, lines 22-24: Support 904 has an annular or circular configuration and a cavity or recess 914 within a tissue contacting surface 912 for holding active electrode 906; see Figs. 39A-39C to see two circular faces of treatment member 910), and an edge delimiting the two side faces (return electrode 908; wherein the return electrode is also the edge delimiting the two side faces; see Fig. 39C), the flat main body having a length (see the length along the longitudinal axis in Fig. 39B), a width (see the width perpendicular to the longitudinal axis in Fig. 39B), and a thickness (see the thickness in Fig. 39C), the thickness extending in a direction between the two side faces (see in Fig. 39C that the thickness extends in a direction between the two side faces), the length and the width being orthogonal to each other (see Fig. 39B) and defining a plane that is orthogonal to the thickness (see Fig. 39B where the two side faces are orthogonal to the thickness) and parallel to the two side faces (see Fig. 39C where the two side faces are parallel to each other), the flat main body including, on a same side face of the two side faces, two electrodes (active electrode 906 & return electrode 908; wherein as defined, merriamwebster.com: face, “the front of something having two or four sides” such that the electrodes 906 and 908 are both disposed on the front side face as shown in the top/front view in Fig. 39B) including electrode surfaces that are isolated from each other on the same side face of the two side faces (Col. 40, lines 12-16: Support 904 supports an active electrode 906 and a return electrode 908 in a spaced apart relationship. The support may be made of an electrically non-conducting material such as, for example, ceramic; wherein the support 904 facilitates the electrical isolation),
wherein the two electrodes are connected or connectable via supply lines to two different output connectors of the HF generator (Col. 40, lines 16-21: active electrode 906 has ends 906a extending into and through openings in support structure 904 to a power supply via one or more conducting members (not shown). Return electrode 908 is operatively connected to the power supply via one or more conducting members (not shown)),
but Davison does not specifically teach wherein the flat main body with the two electrodes is designed to be flexibly bendable.
However, the particular flexibly bendable design used for the flat main body presents no novel or unexpected result over the ceramic material taught by Davison. Choosing a specific material solves no stated problem and would be an obvious matter of design choice within the skill of the art. In re Launder, 42 CCPA 886, 222 F.2d 371, 105 USPQ 446 (1955); Flour City Architectural Metals v. Alpana Aluminum Products, Inc., 454 F. 2d 98, 172 USPQ 341 (8th Cir. 1972); National Connector Corp. v. Malco Manufacturing Co., 392 F.2d 766. 157 USPQ 401 (8th Cir.) cert. denied, 393 U.S. 923, 159 USPQ 799 (1968).
Additionally, the instant application teaches that the material used does not produce an unexpected result, as it would be expected that different materials would enable different material properties based on desired probe characteristics, as demonstrated in paragraph [0016] of the instant application: “Suitable materials for the main body are, for example, plastics, ceramics, or silicones, the temperature stability of which is sufficient for the temperatures occurring during HF surgical procedures. Typical temperatures are approximately 80° C., so that a temperature stability of approx. 100° C. or above is favorable. Silicones, as well as soft plastics, are particularly suitable for flexible HF applicators due to their softness while ceramics and harder plastics can be used for more rigid HF applicators”.
Regarding claim 19, Davison discloses wherein the flat main body is configured to be attached to the at least one HF surgical instrument such that the length of the flat main body extends parallel to a connecting shaft of the at least one HF surgical instrument (Col. 40, lines 9-11: Tissue treatment member 910 includes an electrode support 904 extending from and connected to the distal end of shaft 902 of probe 900).
Regarding claim 20, Davison discloses wherein the length and the width are larger than the thickness of the flat main body (see Figs. 39B-C where the length and width are larger than the thickness of the applicator 910).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Davison in view of Narayan (U.S. Pub. No. 20210259765, previously cited), herein referred to as “Narayan”.
Regarding claim 11, Davison discloses wherein one electrode is set into a recess in the at least one side face of the two side faces of the flat main body, and the electrode surface is flush with the at least one side face of the two side faces of the flat main body (Col. 40, lines 35-37: active electrode 906 is positioned such that a portion of its surface is flush with or just below the tissue-contacting surface 912 of support 904), but Davison fails to disclose wherein the two electrodes are each set into recesses in the same side face of the two side faces of the flat main body, and the electrode surfaces are flush with the same side face of the two side faces of the flat main body.
However, Narayan discloses wherein the two electrodes are each set into recesses in the same side face of the two side faces of the flat main body, and the electrode surfaces are flush with the same side face of the two side faces of the flat main body ([0212]: In the embodiment shown in FIG. 13, ablation components 1350 are ablation electrodes arranged in an array within spade body 1302 so that they are flush with or protrude slightly from contact surface 1315 … The ablation electrodes 1350 may also be different shapes, e.g., oval, round, square, rectangular, etc.; [0215]: As noted above, spade 1310 is formed of a thin, flexible, conformable material, so that contact surface 1315 contacts and conforms to the tissue. While the shape of spade 1310 is depicted as rectangular in FIG. 13, this is intended to be illustrative only and other shapes may be used; [0221]: ablation components 1350 are disposed within contact surface 1315 of spade 1310; [0226]: Spade 1420 is elliptical in shape, which may facilitate positioning of the device near extreme curvatures such as near the pulmonary veins but includes fewer electrodes near its periphery). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrode configuration of Davison to have the recessed electrode configuration of Narayan for the purpose of enabling conformation to the topography of the tissue surface (Narayan: [0214]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Davison in view of Hester et al. (U.S. Pub. No. 20170252089, previously cited), herein referred to as “Hester”.
Regarding claim 17, Davison fails to disclose:
a cooling device that is configured to cool a fluid cooling medium, and
a cooling circuit that is configured to:
introduce the fluid cooling medium into a channel structure of the flat main body of the bipolar HF applicator for cooling the bipolar HF applicator, and
receive the fluid cooling medium that is discharged from the channel structure of the bipolar HF applicator.
However, Hester discloses a cooling device (reservoir 594; Fig. 13A) that is configured to cool a fluid cooling medium ([0128]: The coolant may be remotely cooled in the reservoir and may include a fluid or gas), and
a cooling circuit ([0128]: Input and output coolant lines 590, 592 are attached to a pump) that is configured to:
introduce the fluid cooling medium into a channel structure of the flat main body of the bipolar HF applicator for cooling the bipolar HF applicator (input coolant line 590; [0128]: Input and output coolant lines 590, 592 are attached to a pump and reservoir 594 and extend into the handle 588, through the distal end of the treatment element 582 to the electrode 584 and return back through the shaft 586 and handle 588 to the pump and reservoir 594), and
receive the fluid cooling medium that is discharged from the channel structure of the bipolar HF applicator (output coolant line 592; [0128]: Input and output coolant lines 590, 592 are attached to a pump and reservoir 594 and extend into the handle 588, through the distal end of the treatment element 582 to the electrode 584 and return back through the shaft 586 and handle 588 to the pump and reservoir 594).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the system of Davison to include the cooling device and cooling circuit of Hester for the purpose of the coolant flowing through may allow the treatment element/flat main body to be maintained at a reduced temperature while still allowing current flow to a deeper layers or areas of tissue (Hester: [0128]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794