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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-18 in the reply filed on 04/24/2026 is acknowledged.
Remarks
Claims 19-25 have been cancelled.
Claim 26 has been amended to depend on claim 18.
New claim 27 has been added.
Claim Rejections - 35 USC § 103
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.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6-8, 10, 12, 13, 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over combined embodiments of US Pat Pub No. 20070239098 to Chapman-Jones (hereinafter “Chapman”).
Regarding claim 1. (Original) Chapman discloses an electrode applicator apparatus for treating a tissue (para 0016), the apparatus (fig. 3a-d) comprising: a handle (fig. 3a-d, para 0104, holder 206); an elongate body extending distally from the handle (para 0104, holder 206, any arbitrary portion of the device could be considered to be handle and any arbitrary portion can be the elongated body extending distally from the handle, see figs 3a-3C); a tip region extending distally from the elongate body (para 0109, upper portion of the housing 302, see figs 3b, 3d); a first electrode (para 0017 “pair of electrodes”) extending along a first side of the tip region (para 0109, electrode 306a); a second electrode (para 0017 “pair of electrodes”); extending substantially parallel to the first electrode on the first side of the tip region (para 0109, electrode 306b, see fig. 3d); and a conductive spacer configured to surround and/or cover at least a portion of the first electrode and the second electrode (para 0018 “a conductive gel between the electrodes”), wherein the conductive spacer comprises an electrically conductive material configured to have a conductivity that is less than the conductivity of the first electrode and the second electrode (para 0018, 0022, 0095, etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the embodiments because doing so would result providing a conductive gel between the electrodes which provides the predictable result of providing electrical connection between the electrodes (para 0022).
Regarding claim 2. (Original) Chapman discloses the apparatus of claim 1, wherein the electrically conductive material comprises a polymeric material (para 0025 “gel is a conductive hydropolymer”).
Regarding claim 3. (Original) Chapman discloses the apparatus of claim 1, wherein the electrically conductive material comprises a porous or absorbent material configured to be filled with a conductive fluid (para 0025 “the gel is a conductive hydropolymer containing at least one type of a plurality of treatment molecules which are released when an electrical current from the electrodes passes through the gel.).
Regarding claim 4. (Original) Chapman discloses the apparatus of claim 1, wherein the first electrode and the second electrode comprise wire electrodes (para 0041 “each wire connecting one of the contact electrodes to one of the pair of electrodes”).
Regarding claim 6. (Original) Chapman discloses the apparatus of claim 1, wherein the first electrode and the second electrode extend along a longitudinal length of the first side of the tip region (fig. 3d).
Regarding claim 7. (Original) Chapman discloses the apparatus of claim 1, wherein the first electrode and the second electrode extend proud of the first side of the tip region (fig. 3d; making the electrodes flush, stand proud, etc., are considered mere design choice and well known in the industry See In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947), In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), MPEP 2143 (B) Simple substitution of one known element for another to obtain predictable results;).
Regarding claim 8. (Original) Chapman discloses the apparatus of claim 1, wherein the first electrode and the second electrode are flush with the first side of the tip region (fig. 3d; making the electrodes flush, stand proud, etc., are considered mere design choice and well known in the industry See In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947), In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), MPEP 2143 (B) Simple substitution of one known element for another to obtain predictable results;).
Regarding claim 10. (Original) Chapman discloses the apparatus of claim 1, wherein the conductive spacer comprise a first and a second conductive spacers (claim 40, making the gel separable into multiple gels, See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961), In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)).
Regarding claim 12. (Original) Chapman discloses the apparatus of claim 1, wherein the conductive spacer comprises a plurality of gaps or pores configured to be filled with a filler material to set the conductivity of the conductive spacer (para 0025, 0098, etc.).
Regarding claim 13. (Original) Chapman discloses the apparatus of claim 1, wherein the first electrode and the second electrode are separated by a fixed distance (fig. 3d).
Regarding claim 16. (Original) Chapman discloses the apparatus of claim 1, wherein the tip region comprises a paddle region (the claim does not provide any details regarding the paddle region, as recited in the specification, the tip is also introduced as the paddle region in para 0095-0097, 0234 [stating “a tip region (which may comprise or be formed as a housing, and may be sometimes referred to as a paddle region or a tip housing)”] without reciting what it actually is. Therefore, under its broadest reasonable interpretation, the terms paddle is understood to be referring to the shape of the tip. Since this is not a clear identified shape, then any shape resembling any paddle would read over the claimed limitation. See rejection of claim 1).
Regarding claim 17. (Original) Chapman discloses the apparatus of claim 1, wherein the conductive spacer comprises a sponge material spacer configured to be filled with a saline (it is understood that the gel is capable of being filled with a saline; MPEP 2143 (B) Simple substitution of one known element for another to obtain predictable results).
Claim(s) 5, 11, 18, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over combined embodiments of US Pat Pub No. 20070239098 to Chapman-Jones (hereinafter “Chapman”) in view of US Pat Pub No. 20090270788 to Marenus et al. (hereinafter “Marenus”).
Regarding claim 5. (Currently Amended) Chapman discloses the apparatus of claim 1, but fails to disclose wherein the first side is a tissue facing side and the conductive spacer covers a back surface of the first electrode facing a back side of the tip region which is opposite to the first side of the tip region.
Marenus, from a similar field of endeavor teaches having an electrically conductive medium between the electrodes so that electrical current can flow across the skin surface (abstract, para 0016, 0042, etc.), wherein the hydrogel patch is covering the back-side of electrodes (para 0045, fig. 3B) the material for the electrically conductive medium can be selected to provide any desired cross-flow (para 0042). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Chapman with the teachings of Marenus because doing so would result in selecting the material for the conductive gel which provides the predictable result of achieving a desired cross-flow.
Regarding claim 11. (Original) Chapman discloses the apparatus of claim 10, but fails to disclose wherein the first and the second conductive spacers are separated by a blocker.
Marenus, from a similar field of endeavor teaches having an electrically conductive medium between the electrodes so that electrical current can flow across the skin surface (abstract, para 0016, 0042, etc.) and having a non-conductive material having sufficient tensile strength for supporting the conductive component (para 0047). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Chapman with the teachings of Marenus to provide the predictable result of providing sufficient tensile strength for supporting the conductive component.
Regarding claim 18. (Original) Chapman discloses an electrode applicator apparatus for treating a tissue (para 0016), the apparatus comprising: a handle (fig. 3a-d, para 0104, holder 206); an elongate body extending distally from the handle (para 0104, holder 206, any arbitrary portion of the device could be considered to be handle and any arbitrary portion can be the elongated body extending distally from the handle, see figs 3a-3C); a tip region extending distally from the elongate body (para 0109, upper portion of the housing 302, see figs 3b, 3d); a first electrode (para 0017 “pair of electrodes”) extending along a first side of the tip region (para 0109, electrode 306a); a second electrode (para 0017 “pair of electrodes”) extending parallel to the first electrode on the first side of the tip region(para 0109, electrode 306b, see fig. 3d); and a conductive spacer (para 0018 “a conductive gel between the electrodes”) comprising a sponge material filled or configured to be filled with a conductive fluid (para 0023-0026, 0081, 0098), the conductive spacer at least partially surrounding at least a portion of the first electrode and the second electrode (para 0018 “a conductive gel between the electrodes”), wherein the sponge material together with the conductive fluid achieve a conductivity []; Chapman at paragraph [0022] discloses that the conductive gel provides good electrical connection between the electrodes and a treatment area, but fails to explicitly disclose conductivity of the conductive spacer that is less than the conductivity of the first electrode and the second electrode
Marenus, from a similar field of endeavor teaches having an electrically conductive medium between the electrodes so that electrical current can flow across the skin surface (abstract, para 0016, 0042, etc.) the material for the electrically conductive medium can be selected to provide any desired cross-flow (para 0042). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Chapman with the teachings of Marenus because doing so would result in selecting the material for the conductive gel which provides the predictable result of achieving a desired cross-flow.
Regarding claim 27. (New) Chapman as modified by Marenus renders obvious the apparatus of claim 18, wherein the electrode applicator is configured as a hand- held device, a catheter, a laparoscopic or endoscopic device, a robotic device, a linear probe, an apparatus with clamping jaws, or a percutaneously delivered device (see figs 3a-d).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapman as applied to claims above, and further in view of US Pat Pub No. 20190269904 to Kreis et al. (hereinafter “Kreis”).
Regarding claim 9. (Original) Chapman discloses the apparatus of claim 1, and teaches various amplitudes but fails to explicitly disclose wherein the first electrode and the second electrode are configured to pass electrical pulses having an amplitude of at least 0.1 kV therebetween.
Kreis, from a similar field of endeavor teaches operating the device at various amplitudes including 15kv (para 0108). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Chapman with the known teachings of Kreis to provide the predictable result of operating the device to achieve the desired treatment. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapman as modified by Marenus as applied to claims above, and further in view of US Pat Pub No. 20190269904 to Kreis et al. (hereinafter “Kreis”).
Regarding claim 26. (Currently Amended), Chapman as modified by Marenus renders obvious the apparatus of claim 18, and teaches various amplitudes but fails to explicitly disclose the first electrode and the second electrode are configured to pass electrical pulses having an amplitude of greater than 0.1 kV.
Kreis, from a similar field of endeavor teaches operating the device at various amplitudes including 15kv (para 0108). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Chapman with the known teachings of Kreis to provide the predictable result of operating the device to achieve the desired treatment. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapman as applied to claims above, and further in view of US Pat Pub No. 20110137229 to Palti et al. (hereinafter “Palti”).
Regarding claim 14. (Original) Chapman discloses the apparatus of claim 1, but fails to disclose wherein the conductive spacer has a conductivity that is between 0.01 S/m and 5 S/m.
Palti, from a similar field of endeavor teaches the medium to have a conductivity of 0.5-0.8 s/m. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Chapman with the known teachings of Palti to provide the predictable result of achieving the desired electric flow. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapman as applied to claims above, and further in view of US Pat No. 6056747 to Saadat et al. (hereinafter “Saadat”).
Regarding claim 15. (Original) Chapman discloses the apparatus of claim 1, but fails to disclose further comprising one or more fluid ports in fluid communication with the conductive spacer.
Saadat, from a similar field of endeavor teaches having a fluid supply in fluid communication with the foam-like material (i.e., gel) of the electrodes to supply fluid to the operation site (Col. 2, ln 3-8, 15-19, etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Chapman with the known teachings of Saadat to provide the predictable result of providing fluid to the treatment site.
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796
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