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 .
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.
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, 3-8, 10-12, 14, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palti et al. (US 20050209642 A1) in view of Van Der Beek et al. (US 20130066412 A1), and Casey et al. (US 20220274372 A1).
Regarding claim 1, Palti teaches a method of applying an alternating electric field to a target region in a subject's body ([0067] alternating electrical potential is applied across electrodes 28 and 32) the method comprising applying an alternating voltage between the first conductive electrode element and the second conductive electrode element ([0027] alternating voltage waveform), wherein the applying is performed after positioning the first electrode assembly and the second electrode assembly ([0127] positioning and securing the insulated electrode).
Palti fails to teach the specific steps of positioning the electrode assembly and the structures of the electrode assembly and the conductive adhesive impedes the flow of ions to a level that is less than 20% of a flow rate that would be expected if a hydrogel was used instead of the first conductive adhesive.
Van Der Beek teaches positioning a first electrode assembly (fig 12) at a first position on the subject's body, wherein the first electrode assembly includes a first conductive electrode element having a first front face (conductive layer 74) and a first conductive adhesive disposed on the first front face, in direct contact with the first front face (34 conductive gel that may include adhesive layer), and wherein the first electrode assembly is positioned so that a front face of the first conductive adhesive contacts the subject's body (skin layer 34 is disposed on a skin facing side of the layer of anisotropic material 36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Palti with Van Der Beek because there is some teaching, suggestion, or motivation to do SO. Van Der Beek teaches that the usual configuration of electrodes may create "hot spots" of high current density, or high-current concentrations at a specific location, that can lead to an irritating and/or uncomfortable burning sensation on the skin ([0003]). The structure of Van Der Beek that reads on the current invention addresses the cited motivation. Palti further teaches positioning a second electrode assembly at a second position on the subject's body, wherein the second electrode assembly includes a second conductive electrode element having a second front face and a second conductive adhesive disposed on the second front face, in direct contact with the second front face, and wherein the second electrode assembly is positioned so that a front face of the second conductive adhesive contacts the subject's body (fig. 11 clearly shows two electrodes, duplicating the electrodes of the combination of Van Der Beek and Palti would have been obvious).
The combination of Palti and Van Der Beek fails to teach that the first and second conductive adhesives impede the flow of ions to a level that is less than 20% of the expected rate of a hydrogel. Casey teaches that it is known to use a specific material as an adhesive in a dry electrode arrangement, the material being FLEXcon dry electrodes with FLX068983 OMNI-WAVE as set forth in paragraph 80 for providing a known alternative to hydrogels that have sufficient adhesion and electrically conductive properties for reliable usage as bioelectrodes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Palti and Van Der Beek with use of adhesives that impede the flow of ions to a level that is less than 20% of the expected rate of hydrogels such as using FLEXcon dry electrodes with FLX068983 OMNI-WAVE since such a modification would provide the predictable results of a known alternative to hydrogels that have sufficient adhesion and electrically conductive properties for reliable usage as bioelectrodes. Examiner notes the proffered combination above relates to the selection of a known material for an intended purpose, and the specific claim limitation of impeding the flow of ions to a level that is less than 20% of the expected rate of a hydrogel is merely a resultant effect of the material properties of the material. In other words, the combination relies on the obviousness to use the FLEXcon dry electrodes with FLX068983 OMNI-WAVE adhesive material, which is also the same disclosed material that Applicant relies on in the instant disclosure, and therefore there is a reasonable expectation that the FLEXcon dry electrode with FLX 068983 OMNI-WAVE adhesive would also impede the flow of ions similarly.
Regarding claim 12, Palti teaches an apparatus for applying an alternating electric field to a target region in a subject's body, the apparatus ([0067] alternating electrical potential is applied across electrodes 28 and 32) comprising:
a signal generator configured to apply an alternating voltage between the first conductive electrode element and the second conductive electrode element ([0027] alternating voltage waveform), wherein the alternating voltage has a frequency of 50 kHz - 1 MHz ([0005] the alternating voltage that is applied between the first set of electrode elements and the second set of electrode elements has a frequency between 100 kHz and 300 kHz).
Palti fails to teach the specific steps of positioning the electrode assembly and the structures of the electrode assembly. Van Der Beek teaches a first electrode assembly (fig 12) that includes a first conductive electrode element having a first front face (conductive layer 74) and a first conductive adhesive disposed on the first front face, in direct contact with the first front face (34 conductive gel that may include adhesive layer), wherein the first electrode assembly is configured so that a front face of the first conductive adhesive can be positioned in contact with the subject's body (skin layer 34 is disposed on a skin facing side of the layer of anisotropic material 36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Palti with Van Der Beek because there is some teaching, suggestion, or motivation to do so. Van Der Beek teaches the traditional electrode configuration may create "hot spots" of high current density, or high-current concentrations at a specific location, that can lead to an irritating and/or uncomfortable burning sensation on the skin ([0003]). The structure of Van Der Beek that reads on the current invention addresses the cited motivation.
Palti further teaches positioning a second electrode assembly at a second position on the subject's body, wherein the second electrode assembly includes a second conductive electrode element having a second front face and a second conductive adhesive disposed on the second front face, in direct contact with the second front face, and wherein the second electrode assembly is positioned so that a front face of the second conductive adhesive contacts the subject's body (fig. 11 clearly shows two electrodes, duplicating the electrodes of the combination of Van Der Beek and Palti would have been obvious).
The combination of Palti and Van Der Beek fails to teach that the first and second conductive adhesives impede the flow of ions to a level that is less than 20% of the expected rate of a hydrogel. Casey teaches that it is known to use a specific material as an adhesive in a dry electrode arrangement, the material being FLEXcon dry electrodes with FLX068983 OMNI-WAVE as set forth in paragraph 80 for providing a known alternative to hydrogels that have sufficient adhesion and electrically conductive properties for reliable usage as bioelectrodes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Palti and Van Der Beek with use of adhesives that impede the flow of ions to a level that is less than 20% of the expected rate of hydrogels such as using FLEXcon dry electrodes with FLX068983 OMNI-WAVE since such a modification would provide the predictable results of a known alternative to hydrogels that have sufficient adhesion and electrically conductive properties for reliable usage as bioelectrodes. Examiner notes the proffered combination above relates to the selection of a known material for an intended purpose, and the specific claim limitation of impeding the flow of ions to a level that is less than 20% of the expected rate of a hydrogel is merely a resultant effect of the material properties of the material. In other words, the combination relies on the obviousness to use the FLEXcon dry electrodes with FLX068983 OMNI-WAVE adhesive material, which is also the same disclosed material that Applicant relies on in the instant disclosure, and therefore there is a reasonable expectation that the FLEXcon dry electrode with FLX 068983 OMNI-WAVE adhesive would also impede the flow of ions similarly.
With regard to claims 3-6 and 16-20, Examiner takes the position that all the limitations of these claims are sufficiently taught by the combination of Palti, Van Der Beek, and Casey.
wherein the first conductive adhesive comprises a first dielectric material and a first conductive particles dispersed within the first dielectric material, wherein the second conductive adhesive comprises a second dielectric material and second conductive particles dispersed within the second dielectric material;
wherein the first conductive particles comprise graphite powder, carbon flakes, carbon granules, carbon fibers, carbon nanotubes, carbon nanowires, or carbon black powder or combinations thereof;
wherein the second conductive particles comprise graphite powder, carbon flakes, carbon granules, carbon fibers, carbon nanotubes, carbon nanowires, or carbon black powder, or combination thereof;
wherein the first conductive adhesive comprises at least one of an acrylic polymer and a silicone polymer, and wherein the second conductive adhesive comprises at least one of an acrylic polymer and a silicone polymer;
wherein the first conductive adhesive comprises a dry adhesive, and wherein the second conductive adhesive comprises a dry adhesive
Specifically, Casey teaches the use of the same adhesive material FLEXcon dry electrode with FLX 068983 OMNI-WAVE and the above limitations are considered material properties of the FLEXcon material.
Regarding claim 7, Palti further teaches the alternating voltage has a frequency of 50 kHz - 1 MHz ( [0005] the alternating voltage that is applied between the first set of electrode elements and the second set of electrode elements has a frequency between 100 kHz and 300 kHz).
Regarding claim 8, Palti teaches a method of applying an alternating electric field to a target region in a subject's body, the method ([0067] alternating electrical potential is applied across electrodes 28 and 32) comprising:
applying an alternating voltage between the first conductive electrode element and the second conductive electrode element, wherein the applying is performed after positioning the first electrode assembly and the second electrode assembly ([0127] positioning and securing the insulated electrode, duplication of parts).
Palti fails to teach the specific steps of positioning the electrode assembly and the structures of the electrode assembly. Van Der Beek teaches positioning a first electrode assembly (fig 12) at a first position on the subject's body, wherein the first electrode assembly includes a first conductive electrode element having a first front face (conductive layer 74) and a first biocompatible conductive adhesive disposed on the first front face (34 conductive gel that may include adhesive layer), in direct contact with the first front face, and wherein the first electrode assembly is positioned so that a front face of the first conductive adhesive contacts the subject's body (skin layer 34 is disposed on a skin facing side of the layer of anisotropic material 36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Palti with Van Der Beek because there is some teaching, suggestion, or motivation to do SO. Van Der Beek teaches the traditional electrode configuration may create "hot spots" of high current density, or high-current concentrations at a specific location, that can lead to an irritating and/or uncomfortable burning sensation on the skin ([0003]). The structure of Van Der Beek that reads on the current invention addresses the cited motivation. Palti further teaches positioning a second electrode assembly at a second position on the subject's body, wherein the second electrode assembly includes a second conductive electrode element having a second front face and a second conductive adhesive disposed on the second front face, in direct contact with the second front face, and wherein the second electrode assembly is positioned so that a front face of the second conductive adhesive contacts the subject's body (fig. 11 clearly shows two electrodes, duplicating the electrodes of the combination of Van Der Beek and Palti would have been obvious).
However, the combination Van Der Beek and Palti fails to teach a dry adhesive and that the first and second conductive adhesives impede the flow of ions to a level that is less than 20% of the expected rate of a hydrogel. Casey teaches that it is known to use a specific material as an adhesive in a dry electrode arrangement, the material being FLEXcon dry electrodes with FLX068983 OMNI-WAVE as set forth in paragraph 80, for providing a known alternative to hydrogels that have sufficient adhesion and electrically conductive properties for reliable usage as bioelectrodes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Palti and Van Der Beek with use of adhesives that impede the flow of ions to a level that is less than 20% of the expected rate of hydrogels such as using FLEXcon dry electrodes with FLX068983 OMNI-WAVE since such a modification would provide the predictable results of a known alternative to hydrogels that have sufficient adhesion and electrically conductive properties for reliable usage as bioelectrodes. Examiner notes the proffered combination above relates to the selection of a known material for an intended purpose, and the specific claim limitation of impeding the flow of ions to a level that is less than 20% of the expected rate of a hydrogel is merely a resultant effect of the material properties of the material. In other words, the combination relies on the obviousness to use the FLEXcon dry electrodes with FLX068983 OMNI-WAVE adhesive material, which is also the same disclosed material that Applicant relies on in the instant disclosure, and therefore there is a reasonable expectation that the FLEXcon dry electrode with FLX 068983 OMNI-WAVE adhesive would also impede the flow of ions similarly.
Regarding claim 10, Palti further teaches the alternating voltage has a frequency of 50 kHz - 1 MHz ([0005] the alternating voltage that is applied between the first set of electrode elements and the second set of electrode elements has a frequency between 100 kHz and 300 kHz).
Regarding claim 11 and 14, Palti further teaches the alternating voltage has a frequency of 100 kHz - 500 Hz ([0005] the alternating voltage that is applied between the first set of electrode elements and the second set of electrode elements has a frequency between 100 kHz and 300 kHz). As discussed above, the combination of Palti in view of Van Der Beek and Casey already disclose the dry electrode adhesive material(s) being the FLEXcon dry electrode with FLX 068983 OMNI-WAVE which would exhibit the same impeding properties as claimed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-8, 10-12, 14, and 16-20 have been considered but are moot because the new ground of rejection. The new grounds of rejection relies on newly added Casey to address substantially all of Applicant’s newly amended claim language related to the impeding of ion flow through the adhesive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A STOKLOSA whose telephone number is (571)272-1213. The examiner can normally be reached M-F 930AM-530PM.
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/JOSEPH A STOKLOSA/ Supervisory Patent Examiner, Art Unit 3794
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