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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21, 23, 24, 28 and 32 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Anthony (US 2016/0067103, hereinafter “Anthony”).
In regards to claim 21, Anthony discloses a transducer array (pars. 0106-0170; “[p]referably, the sheet and/or the mask is connectable to 2, 3, 4 or 5 electrodes. The generator produces electrical impulses and the electrodes provide electrostimulation treatment by stimulating the skin”), comprising:
an electrode assembly including an electrode layer comprising one or more electrode (pars. 0106-0107; “[s]aid electrode can also be attached to the skin-facing surface of the support layer…the sheet and/or the mask is connectable to a number of electrodes comprised between 1 and 30, preferably between 5 and 25 electrodes”);
and a non-hydrogel adhesive-free skin-interface material for placement between a surface of the electrode layer and a patient's skin (Fig. 3, element 6; par. 0047, non-adhesive silicone), the non-hydrogel adhesive-free skin- interface material being configured to contact the patient's skin and to conform to contours and/or irregularities of the patient's skin (pars. 0045-0046, 0089).
In regards to claim 23, the non-hydrogel adhesive-free skin- interface material comprises a silicone polymer (par. 0047; non-adhesive silicone), which, optionally, may be crosslinked.
In regards to claim 24, the array further comprises a covering layer disposed on an outwardly facing surface of the electrode layer (element 3, thermoplastic composition layer), the covering layer extending laterally beyond at least a portion of a perimeter of the electrode layer such that at least a portion of the covering layer is in contact with the non-hydrogel adhesive-free skin-interface material (par. 0107; “[t]he electrode can be placed in between the thermoplastic composition layer and the support layer…Preferably, the size of the electrode is larger than the size of the perforations. The electrode is connected to a generator via at least one electric wire which is entered through at least one perforation of the sheet or of the mask. Due to the size difference, the electrode is prevented from passing through the perforation and is thereby fixed to the body part by the mask or the sheet or the patient's skin”), and, optionally, wherein the covering layer is an adhesive tape or bandage.
In regards to claim 28, the non-hydrogel adhesive-free skin- interface material is a nonconductive material with a conductive material suspended therein (par. 0058; silicone and metals such as gold, platinum, zirconium, or copper).
In regards to claim 32, the nonconductive material is a skin mask and the conductive material is conductive particles (pars. 0033, 0058).
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.
Claim 22 is rejected under 35 U.S.C. 102(a)(1) and (2) as anticipated by Anthony or, in the alternative, under 35 U.S.C. 103 as obvious over Anthony in view of Xi (US 2020/0054218, hereinafter “Xi”). Anthony discloses the essential features of the claimed invention, including an interface material made of silicone (par. 0046), which appears to necessarily be viscoelastic, as Applicant has identified silicone as a material possessing this characteristic (par. 0055 of Applicant’s disclosure). Alternatively and additionally, Xi teaches providing an interface material comprising viscoelastic silicone (par. 0038) to provide the predictable results of a material with improved breathability and conformation to the skin (par. 0038). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Anthony by providing an interface material comprising viscoelastic silicone to provide the predictable results of a material with improved breathability and conformation to the skin.
Claims 25, 26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Anthony in view of Byers et al. (US 2019/0167976, hereinafter “Byers”). Anthony discloses the essential features of the claimed invention, including implying that the interface material is a conductive material with no insulating dielectric layer between the electrodes and the patient’s skin (pars. 0106-0107) and comprising a silicone material with conductive particles therein (par. 0058), but does not expressly disclose that the interface material is a conductive material, wherein there is no insulating dielectric layer disposed between the electrodes and the patient’s skin, and wherein the interface material comprises a silicone polymer with conductive carbon particles suspended therein. However, Byers in the same field of endeavor of surface stimulating electrodes teaches an interface material that is a conductive material (pars. 0026; “polymeric material 170 in which an electrically conductive additive is dispersed to impart electrical conductivity”), wherein there is no insulating dielectric layer disposed between the electrodes and the patient’s skin (Figs. 1-3; par. 0029), and wherein the interface material comprises a silicone polymer with conductive carbon particles suspended therein (par. 0027) to provide the predictable results of more effectively serving as contact to receive signals from the muscles of the user and deliver signals to the skin of the user (par. 0025) with a flexible system (par. 0023) and highly conductive material (par. 0027). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Anthony by providing an interface material that is a conductive material, wherein there is no insulating dielectric layer disposed between the electrodes and the patient’s skin, and wherein the interface material comprises a silicone polymer with conductive carbon particles suspended therein to provide the predictable results of more effectively serving as contact to receive signals from the muscles of the user and deliver signals to the skin of the user with a flexible system and highly conductive material.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Anthony and Byers, as applied to claim 25 above, and further in view of Deslauriers (US 2021/0346693, hereinafter “Deslauriers”). Anthony’s modified invention discloses the essential features of the claimed invention, but does not expressly disclose wherein the electrode assembly further comprises a DC blocking capacitor in series with the one or more electrode. However, Deslauriers in the same field of endeavor of skin surface electrodes teaches providing an electrode assembly having a DC blocking capacitor in series with the one or more electrode (Fig. 2, elements 82a and 82b) to provide the predictable results of preventing any DC voltage or DC offset generated by the generator or otherwise present in the electrical signal from passing to or through the patient, this avoiding undesirable consequences, such as electrolysis or excessive heating of the electrodes (par. 0097). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Anthony by providing an electrode assembly having a DC blocking capacitor in series with the one or more electrode to provide the predictable results of preventing any DC voltage or DC offset generated by the generator or otherwise present in the electrical signal from passing to or through the patient, this avoiding undesirable consequences, such as electrolysis or excessive heating of the electrodes.
Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Anthony in view of Hyatt et al. (US 2014/0073896, hereinafter “Hyatt”). Anthony teaches the essential features of the claimed invention, but does not expressly disclose an intermediate layer, which is a conductive material, between the electrode layer and the skin interface material, wherein the intermediate layer is a conductive fabric. However, Hyatt in the same field of endeavor of skin electrodes teaches providing an intermediate layer (Fig. 1, element 18), which is a conductive material, between the electrode layer and the skin interface material, wherein the intermediate layer is a conductive fabric (Fig. 1, element 18; par. 0026) to provide the predictable results of more effectively distributing the current over the electrode as a whole (par. 0025). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Anthony by providing an intermediate layer, which is a conductive material, between the electrode layer and the skin interface material, wherein the intermediate layer is a conductive fabric to provide the predictable results of more effectively distributing the current over the electrode as a whole.
Claims 33, 36, 37 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Byers in view of Anthony and Montecalvo et al. (US 5,330,527, hereinafter “Montecalvo”).
In regards to claim 33, Byers discloses the essential features of the claimed invention, including an electronic apparatus (Figs. 1 and 3) comprising: an electric field generator comprising circuitry configured to generate a TENS signal (par. 0030); a first conducting lead connected to the electric field generator so as to receive the electrical signal (Fig. 3, element 232; par. 0029);a second conducting lead connected to the electric field generator so as to receive the alternating current electrical signal (Fig. 3, element 232; par. 0029); a first transducer array connected to the first conducting lead (Fig. 3, element 230 and Fig. 1, element 122); a second transducer array connected to the second conducting lead (Fig. 3, element 230); wherein the first transducer array comprises: an electrode layer comprising one or more electrode (element 230); and a non-hydrogel skin-interface material for placement between a surface of the electrode layer and a patient's skin (element 122; pars. 0026-0027; silicone with carbon additive), the non-hydrogel skin-interface material being configured to contact the patient's skin and to conform to contours and/or irregularities of the patient's skin (Fig. 2, element 162; par. 0025; a property of silicone). Byers does not expressly and explicitly indicate that the TENS signal is an alternating current electrical signal having an alternating current waveform, or that the silicone is adhesive-free. However, Anthony in the same field of endeavor of skin surface electrodes teaches providing a silicone interface layer that is adhesive-free (par. 0047) to provide the predictable results of comfortable wear and the prevention of adhesion to the skin and/or hair, and conforming to the shape of the body without the need to apply excessive pressure (par. 0089). Further, Montecalvo in the same field of endeavor of skin surface electrodes teaches providing TENS signals in the form of an alternating current electrical signal having an alternating current waveform (col. 2, lines 12-19) to provide the predictable results of a less painful and irritating stimulation signal (col. 2, lines 12-19). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Byers by providing a silicone interface layer that is adhesive-free to provide the predictable results of comfortable wear and the prevention of adhesion to the skin and/or hair, and conforming to the shape of the body without the need to apply excessive pressure; and providing the TENS signals in the form of an alternating current electrical signal having an alternating current waveform to provide the predictable results of a less painful and irritating stimulation signal.
In regards to claims 36 and 37, Byers discloses that the interface material is a nonconductive material with a conductive material suspended therein that comprises a silicone polymer with conductive carbon particles suspended therein (pars. 0026-0027).
In regards to claim 40, Byers discloses the essential features of the claimed invention, including wherein the conductive material is conductive particles (par. 0027), but does not expressly disclose wherein the nonconductive material is a skin mask. However, Anthony teaches providing the skin surface electrode in the form of a skin mask (pars. 0106-0107) to provide the predictable results of medically treating the skin and muscles with an electrode system that conforms to the face (pars. 0106-0107). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Byers by providing the skin surface electrode in the form of a skin mask to provide the predictable results of medically treating the skin and muscles with an electrode system that conforms to the face.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Byers, Anthony, and Montecalvo, as applied to claim 33 above, and further in view of Deslauriers. Byers’ modified invention discloses the essential features of the claimed invention including that the interface material is a conductive material (pars. 0025-0026), but does not expressly disclose wherein the electrode assembly further comprises a first DC blocking capacitor in series with the first conducting lead, and, optionally, a second DC blocking capacitor in series with the second conducting lead. However, Deslauriers in the same field of endeavor of skin surface electrodes teaches providing an electrode assembly having a first DC blocking capacitor in series with the first conducting lead, and, optionally, a second DC blocking capacitor in series with the second conducting lead (Fig. 2, elements 82a and 82b) to provide the predictable results of preventing any DC voltage or DC offset generated by the generator or otherwise present in the electrical signal from passing to or through the patient, this avoiding undesirable consequences, such as electrolysis or excessive heating of the electrodes (par. 0097). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Byers by providing an electrode assembly having a first DC blocking capacitor in series with the first conducting lead, and, optionally, a second DC blocking capacitor in series with the second conducting lead to provide the predictable results of preventing any DC voltage or DC offset generated by the generator or otherwise present in the electrical signal from passing to or through the patient, this avoiding undesirable consequences, such as electrolysis or excessive heating of the electrodes.
Claim 35 is rejected under 103 as obvious over Byers, Anthony, and Montecalvo or, in the alternative, under 35 U.S.C. 103 as obvious over Byers, Anthony, and Montecalvo in view of Xi. Byers’ modified invention discloses the essential features of the claimed invention, including an interface material made of silicone (par. 0026), which appears to necessarily be viscoelastic, as Applicant has identified silicone as a material possessing this characteristic (par. 0055). Alternatively and additionally, Xi teaches providing an interface material comprising viscoelastic silicone (par. 0038) to provide the predictable results of a material with improved breathability and conformation to the skin (par. 0038). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Byers by providing an interface material comprising viscoelastic silicone to provide the predictable results of a material with improved breathability and conformation to the skin.
Claims 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Byers, Anthony, and Montecalvo, as applied to claim 37 above, and further in view of Hyatt. Byers’ modified invention teaches the essential features of the claimed invention, but does not expressly disclose an intermediate layer, which is a conductive material, between the electrode layer and the skin interface material, wherein the intermediate layer is a conductive fabric. However, Hyatt in the same field of endeavor of skin electrodes teaches providing an intermediate layer (Fig. 1, element 18), which is a conductive material, between the electrode layer and the skin interface material, wherein the intermediate layer is a conductive fabric (Fig. 1, element 18; par. 0026) to provide the predictable results of more effectively distributing the current over the electrode as a whole (par. 0025). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Byers by providing an intermediate layer, which is a conductive material, between the electrode layer and the skin interface material, wherein the intermediate layer is a conductive fabric to provide the predictable results of more effectively distributing the current over the electrode as a whole.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kosierkiewicz (US 11,806,521) is another example of a body surface electrode utilizing a silicone layer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL W KAHELIN/ Primary Examiner, Art Unit 3792