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 .
Response to Arguments
Applicant's arguments filed April 1, 2026 have been fully considered but they are not persuasive.
Applicant argues “As per claim 1, the Babaev-Reinhold combination fails to disclose or suggest "when viewed in a direction perpendicular to the x-y plane, a first non-conductive edge portion is located adjacent to and extends along an outer edge of the conductive adhesive region and forms at least a portion of an outer perimeter of the adhesive layer." In rejecting claim 1, the Office Action aligns the conductive surface 40 of the conductive layer 10 in FIG. 1(a) of Babaev with the recited "conductive adhesive region" and apparently aligns the area 60 of the conductive layer 10 in FIG. 1(a) of Babaev with the recited "non-conductive edge portion." Office Action, page 3. The Office Action states that Babaev fails to disclose that the area 60 includes "an adhesive devoid of electrically conductive particles."
However, this interpretation “apparently aligns the area 60 of the conductive layer 10 in FIG. 1(a) of Babaev with the recited "non-conductive edge portion." Office Action, page 3. The Office Action states that Babaev fails to disclose that the area 60 includes "an adhesive devoid of electrically conductive particles" is not correct. On page 3 of the Office Action clearly states “As to claim 1, Babaev discloses a conductive layer (depicted as 10 in Figure 1) with an outer edge, depicted as 30 in Figure 1 that is devoid of a conductive surface, depicted as 40 in Figure 1 ([0024-0025]) wherein the conductive surfaces can be fashioned from “conductive adhesives”([0029]). “
Additionally, paragraphs 24-25 cited by the Office Action recite:
[0024] FIG. 1(a) depicts the conductive layer (10) of an electrode (20) of the present invention. The outer perimeter (30) is the boundary of the geometric region encompassing the conductive surface (40) of the conductive layer (10). The inner perimeter (50) is the boundary of the area (60) within the outer perimeter (30) that does not contain a conductive surface (40). The inner perimeter (50) in this electrode is in a spiral shape. However, other sizes or shapes of inner perimeters, or a combination thereof, may be utilized.
[0025] FIG. 1(b) depicts the conductive layer (10) of an electrode (20) of the present invention. The outer perimeter (30) is the boundary of the geometric region encompassing the conductive surface (40) of the conductive layer (10). The inner perimeter (50) is the boundary of the area (60) within the outer perimeter (30) that does not contain a conductive surface (40). The inner perimeter (50) in this electrode is in a spiral shape. This is the same shape of the electrode contained in FIG. 1(a) but with the conductive surface and non-conductive surface within the outer perimeter inverted.
Therefore, since the Applicant’s arguments are based on incorrect assessment of the rejection for the reasons stated above, the arguments are considered unpersuasive. Therefore, the pending claims stand rejected as previously made of record and provided below.
Furthermore, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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 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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Babaev (US 20070239250 A1) in view of Reinhold, Jr. (US 3,911,906).
As to claim 1, Babaev discloses a conductive layer (depicted as 10 in Figure 1) with an outer edge, depicted as 30 in Figure 1 that is devoid of a conductive surface, depicted as 40 in Figure 1 ([0024-0025]) wherein the conductive surfaces can be fashioned from “conductive adhesives”([0029]). Therefore, Babaev discloses an adhesive layer extending in an x-y plane and having an adhesive layer outer edge and a non-conductive edge that extends at least a portion of the outer perimeter. Babaev discloses the invention substantially as claimed but does not explicitly disclose whether all of the conductive layer (depicted as 10 in Figure 1) is all comprised of an adhesive material (thus making the conductive portion from a conductive adhesive and the non-conductive portion from a non-conductive adhesive) or the adhesive includes a matrix material with a plurality of electrically conductive particles embedded at least partially within.
Reinhold, Jr. discloses “a tacky skin-engaging surface formed by a thin flexible layer of pressure sensitive adhesive material having fine electrically conductive particles dispersed throughout including the skin-engaging surface in an amount sufficient to provide an effective electrical connection with the engaged area of the skin through the layer by particle to particle contact while permitting the skin-engaging surface of the layer to remain tacky prior to skin engagement” (col. 2, lines 42-51; Figure 1-2). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the conductive adhesive of Babaev to be comprised of a plurality of electrically conductive particles embedded at least partially within the adhesive matrix material as disclosed by Reinhold, Jr., since conductive adhesives, comprised of embedded electrically conductive particles, are well known in medical stimulation art (Reinhold, Jr., col. 4, lines 31-52) and 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 (See MPEP 2144.07). Furthermore, such a modification of Babaev would provide the predictable results of modifying the materials to ensure sufficient engagement with the patient’s skin to facilitate treatment.
Additionally, Babaev does not explicitly disclose the entire skin contacting surface is adhesive (thus making the conductive portion from a conductive adhesive and the non-conductive portion from a non-conductive adhesive). Reinhold, Jr. discloses an adhesive layer disposed across the entire skin contacting surface (Figure 1-2; Abstract). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the entire conductive layer (depicted as 10 in Figures 1-4) to be comprised from an adhesive as disclosed by Reinhold, Jr. in order to provide the predictable results of ensuring sufficient skin engagement and electrical contact. Therefore, the modified Babaev discloses the conductive layer (depicted as 10 in Figures 1-4) is all comprised of an adhesive material with the conductive portion from a conductive adhesive (a plurality of electrically conductive particles embedded at least partially within the adhesive matrix material) and the non-conductive portion from a non-conductive adhesive.
As to claim 2, the modified Babaev discloses the invention substantially as claimed but does not explicitly disclose the dimensions of the first non-conductive edge portion of the adhesive layer. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the dimension of the first non-conductive edge portion extends at least 1 mm from the adhesive layer outer edge into the adhesive layer in a direction perpendicular to the adhesive layer outer edge, 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). Furthermore, such a modification would provide the predictable results of modifying the device to meet specific patient therapeutic needs and requirements.
As to claim 3, Babaev, and thus the modified Babaev, disclose the adhesive layer has a substantially square or rectangular shape, or substantially square or rectangular shape with rounded corners when viewed in the direction perpendicular to the x-y plane (Babeav, Figures 2-4).
As to claim 4, Babaev, and thus the modified Babaev, disclose when viewed in the direction perpendicular to the x-y plane, the conductive adhesive region has a substantially square or rectangular shape, or substantially square or rectangular shape with rounded corners, and the first non-conductive edge portion is located adjacent to and extends along four outer edges of the conductive adhesive region, the four outer edges being connected by corners or rounded corners (Babeav, Figures 2-4).
As to claim 5, Babaev, and thus the modified Babaev, disclose when viewed in the direction perpendicular to the x-y plane, the conductive adhesive region has a substantially square or rectangular shape, or substantially square or rectangular shape with rounded corners and the first non-conductive edge portion is located adjacent to and extends along a first outer edge of the conductive adhesive region, and a second non-conductive edge portion is located adjacent to and extends along a second outer edge of the conductive adhesive region opposite the first outer edge of the conductive adhesive region, each forming at least a portion of the outer perimeter of the adhesive layer (Babeav, Figures 2-4).
As to claim 6, Babaev, and thus the modified Babaev, disclose when viewed in the direction perpendicular to the x-y plane, the first and second non-conductive edge portions are separated from each other, such that electrically conductive particles are located along a third outer edge of the conductive adhesive region connecting the first and second outer edges of the conductive adhesive region, and electrically conductive particles are located along a fourth outer edge of the conductive adhesive region connecting the first and second outer edges of the conductive adhesive region (Babeav, Figures 2-4).
As to claim 7, Babaev, and thus the modified Babaev, disclose the adhesive layer has a circular, oval, ovoid, ovaloid, or elliptical shape when viewed in the direction perpendicular to the x-y plane (Babeav, Figures 1-4).
As to claim 8, Babaev, and thus the modified Babaev, disclose when viewed in the direction perpendicular to the x-y plane, the first non-conductive edge portion is located adjacent to and extends along the outer edge of the conductive adhesive region and forms the entire outer perimeter of the adhesive layer (Babeav, Figures 1-4).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over the modified Babaev, as applied to claims 1-8 above, in further view of Esty et al. (US 4,166,465).
As to claim 9, the modified Babaev disclose the invention substantially as claimed but does not explicitly disclose that the conductive particles are conductive fibers. Esty et al. discloses the inclusion of conductive fibers (col. 4, lines 22-34) on a skin contacting electrode. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the particles of the modified Babaev to be fibers as disclosed by Esty et al., 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 (See MPEP 2144.07). Furthermore such a modification would provide the predictable results of optimizing cost and performance to meet specific patient therapeutic needs and requirements.
As to claim 10, the modified Babaev disclose the invention substantially as claimed but does not explicitly disclose that the conductive particles are comprise graphite. Esty et al. discloses the inclusion of conductive graphite particles (col. 4, lines 22-34) on a skin contacting electrode. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the conductive particles of the modified Babaev to be graphite as disclosed by Esty et al., 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 (See MPEP 2144.07). Furthermore such a modification would provide the predictable results of optimizing cost and performance to meet specific patient therapeutic needs and requirements.
As to claim 11, the modified Babaev disclose the invention substantially as claimed but does not explicitly disclose that the conductive particles comprise a sheet of fibers. Esty et al. discloses the inclusion of conductive fibers (col. 4, lines 22-34) that can be configure as a sheet (col. 4, lines 22-65) on a skin contacting electrode. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the particles of the modified Babaev to be a sheet of fibers as disclosed by Esty et al., 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 (See MPEP 2144.07). Furthermore such a modification would provide the predictable results of optimizing cost and performance to meet specific patient therapeutic needs and requirements.
Claims 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Munch et al. (US 4,736,752) in view of Esty et al. (US 4,166,465) in further view of Babaev (US 2007/0239250 A1).
As to claim 12, Munck et al. discloses a substrate (thin flexible backing, depicted as 12 in Figure 1; col. 4, lines 20-38); at least one electrode element coupled to the substrate (conductive grid, depicted as 20 in Figures 1-2; col. 4, lines 20-30), the at least one electrode element being capable of delivering tumor treating fields to a subject’s body (In regards to the electrode “being capable of delivering tumor treating fields”, it has been held that the recitation that an element is “capable of” performing a function in not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138. As such, since the electrode is capable of delivering energy to the subject, the electrode is “capable of delivering tumor treating fields”); and an adhesive layer (conductive adhesive, depicted as 50 in Figure 1 ; col. 4, lines 39-54) located on an opposite side of the at least one electrode element from the substrate (Figure 1), the adhesive layer comprising an electrically conductive adhesive region (col. 4, lines 39-54 and col. 5, lines 3-8), wherein: the electrically conductive adhesive region has an areal footprint that overlays one, or more than one, electrode element (Figure 1).
Munck et al. discloses the invention substantially as claimed but does not explicitly disclose that the conductive adhesive comprises conductive fibers embedded at least partially within an adhesive matrix material. Esty et al. discloses the conductive adhesive includes conductive fibers (col. 4, lines 22-34) on a skin contacting electrode. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the conductive adhesive of Munck et al. to include fibers as disclosed by Esty et al., 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 (See MPEP 2144.07). Furthermore such a modification would provide the predictable results of optimizing cost and performance to meet specific patient therapeutic needs and requirements.
Thus, the modified Munck et al. discloses the invention substantially as claimed with an electrically conductive adhesive region comprises a plurality of electrically conductive fibers embedded at least partially within an adhesive matrix material with a non-conductive perimeter (depicted as 42 in Figure 1 of Munck et al.) but does not explicitly disclose that the non-conductive perimeter of an adhesive devoid of electrically conductive fibers. Babaev disclose an electrode surface having an adhesive layer with non-conductive edges that extends at least a portion of the outer perimeter (Babaev, Figures 1-4). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the conductive adhesive geometry of the modified Munck et al. with the conductive adhesive geometry of Babaev to form a non-conductive boarder (Figures 1-4) in order to provide the predictable results of modifying the construction of the device to meet specific patient therapeutic needs and requirements.
As to claim 13, the modified Munck et al. discloses when viewed in the direction perpendicular to the face of the substrate, a second area defining a second portion of the outer perimeter of the adhesive layer has electrically conductive fibers, and the transducer apparatus further comprises a non-conductive material border disposed over the second area, the non-conductive material border being electrically non-conductive (Babaev, Figures 1-4).
As to claim 14, the modified Munck et al. discloses when viewed in a direction parallel to the face of the substrate, the non-conductive material border covers a full thickness of the adhesive layer in the direction perpendicular to the face of the substrate (Munck et al., Figure 1).
As to claim 15, the modified Munck et al. discloses the invention substantially as claimed but does not explicitly disclose an outer edge of the non-conductive material border extends at least 1 mm outside of the second portion of the outer perimeter of the adhesive layer. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the dimension of the first non-conductive edge portion extends at least 1 mm from the adhesive layer outer edge into the adhesive layer in a direction perpendicular to the adhesive layer outer edge, 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). Furthermore, such a modification would provide the predictable results of modifying the device to meet specific patient therapeutic needs and requirements.
As to claim 16, the modified Munck et al. discloses when viewed in the direction perpendicular to the face of the substrate, a third area defining a third portion of the outer perimeter of the adhesive layer opposite the second portion of the outer perimeter has electrically conductive fibers, and a second non-conductive material border is disposed over the third area, the second non- conductive material border being electrically non-conductive (Babaev, Figures 1-4).
As to claim 17, the modified Munck et al. discloses when viewed in the direction perpendicular to the face of the substrate, the first area located adjacent to and extending along at least the first portion of the outer perimeter of the electrically conductive adhesive region extends along the entire outer perimeter of the electrically conductive adhesive region, and forms an entire outer perimeter of the adhesive layer that is non-conductive (Munck et al., Figure 1; Babaev, Figures 1-4).
As to claim 18, the modified Munck et al. discloses the invention substantially as claimed but does not explicitly disclose a layer of anisotropic material located between one or more than one electrode element and the electrically conductive adhesive region. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the matierials employed with the modified Munck et al. to incorporate a layer of anisotropic material located between one or more than one electrode element and the electrically conductive adhesive region, 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 (See MPEP 2144.07). Furthermore such a modification would provide the predictable results of optimizing cost and performance to meet specific patient therapeutic needs and requirements.
As to claim 19, the modified Munck et al., as applied to claim 18 above, discloses when viewed in the direction perpendicular to the face of the substrate, the first portion of the outer perimeter of the adhesive layer that is electrically non- conductive extends outward beyond an outer perimeter of the layer of anisotropic material (Munck et al., Figure 1; Babaev, Figures 1-4).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Babaev (US 20070239250 A1) in view of Reinhold, Jr. (US 3,911,906) in further view of Esty et al. (US 4,166,465).
Babaev discloses a conductive layer (depicted as 10 in Figure 1) with an outer edge, depicted as 30 in Figure 1 that is devoid of a conductive surface, depicted as 40 in Figure 1 ([0024-0025]) wherein the conductive surfaces can be fashioned from “conductive adhesives”([0029]). Therefore, Babaev discloses an adhesive layer extending in an x-y plane and having an adhesive layer outer edge and a non-conductive edge that extends at least a portion of the outer perimeter. Babaev discloses the invention substantially as claimed but does not explicitly disclose whether all of the conductive layer (depicted as 10 in Figure 1) is all comprised of an adhesive material (thus making the conductive portion from a conductive adhesive and the non-conductive portion from a non-conductive adhesive) or the adhesive includes a matrix material with a plurality of electrically conductive particles embedded at least partially within.
Reinhold, Jr. discloses “a tacky skin-engaging surface formed by a thin flexible layer of pressure sensitive adhesive material having fine electrically conductive particles dispersed throughout including the skin-engaging surface in an amount sufficient to provide an effective electrical connection with the engaged area of the skin through the layer by particle to particle contact while permitting the skin-engaging surface of the layer to remain tacky prior to skin engagement” (col. 2, lines 42-51; Figure 1-2). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the conductive adhesive of Babaev to be comprised of a plurality of electrically conductive particles embedded at least partially within the adhesive matrix material as disclosed by Reinhold, Jr., since conductive adhesives, comprised of embedded electrically conductive particles, are well known in medical stimulation art (Reinhold, Jr., col. 4, lines 31-52) and 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 (See MPEP 2144.07). Furthermore, such a modification of Babaev would provide the predictable results of modifying the materials to ensure sufficient engagement with the patient’s skin to facilitate treatment.
Additionally, Babaev does not explicitly disclose the entire skin contacting surface is adhesive (thus making the conductive portion from a conductive adhesive and the non-conductive portion from a non-conductive adhesive). Reinhold, Jr. discloses an adhesive layer disposed across the entire skin contacting surface (Figure 1-2; Abstract). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the entire conductive layer (depicted as 10 in Figures 1-4) to be comprised from an adhesive as disclosed by Reinhold, Jr. in order to provide the predictable results of ensuring sufficient skin engagement and electrical contact. Therefore, the modified Babaev discloses the conductive layer (depicted as 10 in Figures 1-4) is all comprised of an adhesive material with the conductive portion from a conductive adhesive (a plurality of electrically conductive particles embedded at least partially within the adhesive matrix material) and the non-conductive portion from a non-conductive adhesive.
The modified Babaev disclose the invention substantially as claimed but does not explicitly disclose that the conductive particles are conductive fibers. Esty et al. discloses the inclusion of conductive fibers (col. 4, lines 22-34) on a skin contacting electrode. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the particles of the modified Babaev to be fibers as disclosed by Esty et al., 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 (See MPEP 2144.07). Furthermore such a modification would provide the predictable results of optimizing cost and performance to meet specific patient therapeutic needs and requirements.
Therefore, the modified Babaev discloses an adhesive layer extending in an x-y plane, the adhesive layer comprising: an adhesive matrix material; and a plurality of electrically conductive fibers embedded at least partially within the adhesive matrix material, wherein, when viewed in a direction perpendicular to the x-y plane, the plurality of electrically conductive fibers are located within a fiber region of the adhesive layer defined by a first areal footprint, and the adhesive layer further comprises at least one non-fiber region located along one or more portions of an outer perimeter of the fiber region of the adhesive layer, each non-fiber region being devoid of electrically conductive fibers.
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 ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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