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 07/21/2025 have been fully considered but they are not persuasive.
In response to applicants’ arguments related to claim 11. Applicant stated features “cup-shaped element with a matrix of rubbery material, inside which matrix particles of conductive material are embedded” ((Figure 29; Specifically, Vitale teaches a patient contact area that is seen as a cup element and ([00136] lines 1-6; specifically, Vitale teaches that platinum impregnated rubbers may be used wherein platinum impregnated rubbers are seen as a matrix of rubbery material, inside which matrix particles of conductive material are embedded) , “conductive material consist of one or more layers of conductive ink” (“ region 3204 that is infused with a conductive material, e.g., MXene material, graphene, and the like.” Wherein MXene is seen as a conductive ink) and “The electrode of claim 11 therefore provides a soft and deformable conduction part” (([0080] lines 1-5; Specifically, Vitale teaches the encapsulating the embodiment in a flexible elastomeric film which is seen as a soft and/or flexible material). However, these elements are taught by Vitale and therefore the argument is not persuasive.
In response to applicant’s argument that “The particles of conductive material are dispersed inside the rubbery material, in order to maintain the softness of the cup shaped element and, at the same time, the electric conductivity.
This combination provides that a deformation of the cup element does not create impedance variations of the detected signal, which can lead to incorrect readings and transductions of the signal itself. (See paragraph [25] of Applicant's originally-filed specification).” , “The layer of conductive material allows to increase the electrical conductivity of the electrode.“ and “In this way, the layer of conductive material has the same capabilities and properties as the cup element in terms of flexibility and softness, so as to allow the deformation of the cup element to be followed by that of the conductive coating, without the latter being able to present cracks or breakages which compromise the conduction of the signal detected by the electrode.
Thus, the conductivity increases, while maintaining the flexibility of the electrode “, “In this way, the layer of conductive material has the same capabilities and properties as the cup element in terms of flexibility and softness, so as to allow the deformation of the cup element to be followed by that of the conductive coating, without the latter being able to present cracks or breakages which compromise the conduction of the signal detected by the electrode.“ , “Thus the conductivity increases, while maintaining the flexibility of the electrode.“ and “Further, the addition of a conductive material of conductive ink allows the electrode of claim 11 to maintain flexibility and conductivity “ Vitale teaches these elements and therefore would have these properties.
In response to argument of the anticipation of a cup shaped element. Vitale “aperture or other opening 3208 can be formed in the insulating material 3202” ([0172]). In the middle panel of figure 29 the cup element is illustrated taking cup element at its broadest reasonable interpretation, the middle panel of 29 meets the limitation of “cup element”.
Given the above reasoning the rejection of claim 11 stands.
Regarding claims 13 and 18. Both claims 13 and 18 are still rejected because the rejection of claim 11 stands.
Regarding canceled claims, the cancelation of claims 1-10, 12 and 15 are excepted
Claim Rejections - 35 USC § 102
Claim(s) 11, 14-17, 19-28 and 30-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vitale et. al. (US 20240090814 A1) herein referred to as “Vitale”.
Regarding Claim 11, Vitale teaches: An electrode for recording electroencephalographic signals and/or for stimulating a patient the electrode comprising ([00148] lines 1-5; specifically Vitale teaches the electrodes are capable of being used in EEG): a contact part (Figure 3 B; Specifically the electrode contact area), a transmission part (Figure 3B; Specifically, the tapered area connected to the contact area, see annotated figure 3 below, where the transmission part is the arrow pointing to the tapered area), and a layer of electrolyte material configured to be in contact with the patient's skin and configured to be interposed between the patient's skin and the contact part ([0136] lines 1-3; Specifically, Vitale teaches that conductive extensions such as hydrogels may be used), wherein said contact part and/or said transmission part includes a soft and/or flexible materials ([0080] lines 1-5; Specifically Vitale teaches the encapsulating the embodiment in a flexible elastomeric film which is seen as a soft and/or flexible material) wherein said contact part comprises a cup element adapted to house at least in part said layer of electrolyte material (Figure 29; Specifically, Vitale teaches a patient contact area that is seen as a cup element see the arrow pointing to middle panel in figure 29 below), wherein the cup element includes a matrix of rubbery material, wherein particles of conductive material are embedded inside said matrix ([00136] lines 1-6; specifically, Vitale teaches that platinum impregnated rubbers may be used wherein platinum impregnated rubbers are seen as a matrix of rubbery material, inside which matrix particles of conductive material are embedded), wherein a layer of conductive material is provided, interposed, at least in part, between the cup element and the layer of electrolyte material, and wherein said layer of conductive material consists of one or more layers of conductive ink. ([0080]; “encapsulated in ˜1 mm-thick layers of polydimethylsiloxane (PDMS)” and [0172];” As shown in the middle panel, an aperture or other opening 3208 can be formed in the insulating material 3202 (and in the further insulating material 3206, if present) so as to expose the sensing region 3204. The aperture can be circular, but this is not a requirement. As shown, the top surface of the sensing region can be located beneath the top surface of the insulating material 3202 as well as beneath the top surface of the further insulating material 3206”, [0171]; “ region 3204 that is infused with a conductive material, e.g., MXene material, graphene, and the like.” Wherein MXene is seen as a conductive ink)
Regarding claim 14, Vitale teaches: The electrode according to claim 11. Vitale further teaches: wherein said transmission part includes a wire of conductive material, wherein said wire is fixed to said cup element, wherein said transmission part further includes a sheath of rigid material provided at a connection between the wire and said cup element. ([0047] lines 1 -6; Specifically, Vitale teaches a conductive material used to create the sensors. And figure 3; Specifically, Vitale teaches the electrode array and the long portion of the array is seen as a wire.)
Regarding claim 16, Vitale teaches: The electrode according to claim 11. Vitale further teaches: wherein said electrode includes a plurality of branches (Figure 3; Specifically Vitale teaches a plurality of branches), each of said plurality of branches including a head portion and a tail portion (Figure 3; Specifically, Vitale teaches the head element as being the patient contact area and the tail portion to be the thin lines protruding from the head element), wherein said contact part includes the head parts and said transmission part includes the tail parts (Figure 3; Specifically, each contact part is within the head parts and each transmission part within the tail parts), wherein each of said plurality of branches further includes a flexible support element , each of the flexible support elements including at least one conductive element ([0047] lines 1-6; specifically, Vitale teaches of a conductive material used to create the apparatus and [0080] lines 1-5 specifically, Vitale teaches of the apparatus being encapsulated in a flexible elastomeric film), wherein each of the flexible support elements has a head terminal and a tail terminal (Figure 3; specifically, Vitale teaches electrode with a support element with a head terminal near the patient contact area and the tail terminal opposite of the head terminal), and wherein each of the conductive elements includes having at least one head contact and at least one tail contact (Figure 3; specifically, as mentioned earlier the conductive element is infused throughout the electrode and therefore would have a head and tail contact), respectively arranged at the head end and tail end of the flexible support element, each of said conductive elements including a conductive track made of a layer of conductive ink deposited on the flexible support element. ({0080] lines 1-5; specifically, Vitale teaches the electrode made with a substrate infused with conductive ink).
Regarding claim 17, Vitale teaches: The electrode according to claim 16. Vitale further teaches: wherein said plurality of branches have a length less than a value between 23 centimetres and 27 centimetres. ([0034] lines 1-4; specifically, Vitale teaches the branches having a length of 20 cm which is seen as less than the range as claimed).
Regarding claim 19, Vitale teaches: The electrode according to claim 16. Vitale further teaches: wherein each of the head contacts has a width between 3 millimetres and 20 millimetres, and each of the tail contacts has a width between 3 millimetres and 16 millimetres. ([0034] lines 1-4; specifically, Vitale teaches the contact head width 3 millimeters and the tail is seen as a similar width as the dimensions for the structures were 20 cmx3mmx285 micrometers).
Regarding claim 20, Vitale teaches: The electrode according to claim 16. Vitale further teaches: wherein each of said branches are arranged in a coplanar manner and so-as-to converge with the tail parts thereof towards a terminal end (Figure 11 A; specifically, Vitale teaches the construction of the electrodes in a coplanar manor), and wherein each of the branches are further being arranged symmetrically with respect to a plane perpendicular to the plane of coplanarity. (Figure 3 which shows that the branches are arranged in such a manner).
Regarding claim 21, Vitale teaches: The electrode according to claim 16. Vitale further teaches: wherein each of said branches are arranged in a coplanar manner (Figure 3 which shows that the branches are arranged in such a manner) and converge with the tail parts thereof towards a terminal end (Figure 11 A; specifically, Vitale teaches the construction of the electrodes in a coplanar manor).
Regarding claim 22, Vitale teaches: The electrode according to claim 16. Vitale further teaches: wherein each of the head contacts has a width between 3 millimetres and 20 millimetres. ([0034] lines 1-4; specifically, Vitale teaches the branches having a length of 20 cm).
Regarding claim 23, Vitale teaches: The electrode according to claim 16. Vitale further teaches: wherein each of the tail contacts has a width between 3 millimetres and 16 millimetres. ([0034] lines 1-4; specifically, Vitale teaches the contact head width 3 millimeters and the tail is seen as a similar width as the dimensions for the structures were 20 cmx3mmx285 micrometers).
Regarding claim 24, Vitale teaches: The electrode according to claim 11. Vitale further teaches: wherein said contact part comprises the cup element adapted to house entirely said layer of electrolyte material. (Figure 29; Specifically, Vitale teaches a patient contact area that is seen as a cup element see the arrow pointing to middle panel in figure 29 below, [0136] lines 1-3; Specifically, Vitale teaches that conductive extensions such as hydrogels may be used. The contact portion being of a cup structure and the use of hydrogel being taught it seen as being able to house entirely electrolyte material)
Regarding claim 25, Vitale teaches: The electrode according to claim 11. Vitale further teaches: wherein said contact part includes a soft and/or flexible material. ([0080] lines 1-5; Specifically Vitale teaches the encapsulating the embodiment in a flexible elastomeric film which is seen as a soft and/or flexible material)
Regarding claim 26, Vitale teaches: The electrode according to claim 11. Vitale further teaches: wherein said transmission part includes a soft and/or flexible material. ([0080] lines 1-5; Specifically, Vitale teaches the encapsulating the embodiment in a flexible elastomeric film which is seen as a soft and/or flexible material
Regarding claim 27, Vitale teaches: The electrode according to claim 11. Vitale further teaches: wherein said contact part and said transmission part includes a soft and/or flexible material. ([0080] lines 1-5; Specifically Vitale teaches the encapsulating the embodiment in a flexible elastomeric film which is seen as a soft and/or flexible material
Regarding claim 28, Vitale teaches: An electrode for recording electroencephalographic signals and/or for stimulating a patient, the electrode comprising ([00148] lines 1-5; specifically Vitale teaches the electrodes are capable of being used in EEG): a contact part (Figure 3 B; Specifically the electrode contact area), a transmission part (Figure 3B; Specifically, the tapered area connected to the contact area, see annotated figure 3 below, where the transmission part is the arrow pointing to the tapered area), and a layer of electrolyte material configured to be in contact with the patient's skin and configured to be interposed between the patient's skin and the contact part ([0136] lines 1-3; Specifically, Vitale teaches that conductive extensions such as hydrogels may be used), wherein said contact part and/or said transmission part includes a soft and/or flexible material ([0080] lines 1-5; Specifically Vitale teaches the encapsulating the embodiment in a flexible elastomeric film which is seen as a soft and/or flexible material), wherein said contact part comprises a cup-shaped element adapted to house at least in part said layer of electrolyte material (Figure 29; Specifically, Vitale teaches a patient contact area that is seen as a cup element see the arrow pointing to middle panel in figure 29 below), wherein the cup-shaped element includes a matrix of rubbery material, wherein particles of conductive material are embedded inside said matrix, wherein a layer of conductive material is provided, interposed, at least in part, between the cup-shaped element and the layer of electrolyte material, and wherein said layer of conductive material includes of one or more layers of conductive ink. ([0172];” As shown in the middle panel, an aperture or other opening 3208 can be formed in the insulating material 3202 (and in the further insulating material 3206, if present) so as to expose the sensing region 3204. The aperture can be circular, but this is not a requirement. As shown, the top surface of the sensing region can be located beneath the top surface of the insulating material 3202 as well as beneath the top surface of the further insulating material 3206”, [0171]; “ region 3204 that is infused with a conductive material, e.g., MXene material, graphene, and the like.” Wherein MXene is seen as a conductive ink)
Regarding claim 30, Vitale teaches: The electrode according to claim 28. Vitale further teaches: wherein said transmission part includes a wire of conductive material, wherein said wire is fixed to said cup-shaped element, wherein said transmission part further includes a sheath of rigid material provided at a connection between the wire and said cup-shaped element. ([0047] lines 1 -6; Specifically, Vitale teaches a conductive material used to create the sensors. And figure 3; Specifically, Vitale teaches the electrode array and the long portion of the array is seen as a wire.)
Regarding claim 31, Vitale teaches: The electrode according to claim 28. Vitale further teaches: wherein said electrode includes a plurality of branches (Figure 3; Specifically Vitale teaches a plurality of branches), each of said plurality of branches including a head portion and a tail portion (Figure 3; Specifically, Vitale teaches the head element as being the patient contact area and the tail portion to be the thin lines protruding from the head element), wherein said contact part includes the head parts and said transmission part includes the tail parts (Figure 3; specifically, Vitale teaches electrode with a support element with a head terminal near the patient contact area and the tail terminal opposite of the head terminal), wherein each of said plurality of branches further includes a flexible support element ([0047] lines 1-6; specifically, Vitale teaches of a conductive material used to create the apparatus and [0080] lines 1-5 specifically, Vitale teaches of the apparatus being encapsulated in a flexible elastomeric film) , each of the flexible support elements including at least one conductive element (Figure 3; specifically, as mentioned earlier the conductive element is infused throughout the electrode and therefore would have a head and tail contact) , wherein each of the flexible support elements has a head terminal and a tail terminal ([Figure 3]), and wherein each of the conductive elements includes at least one head contact and at least one tail contact ([Figure 3]), respectively arranged at the head end and tail end of the flexible support element ([Figure 3]), each of said conductive elements including a conductive track made of a layer of conductive ink deposited on the flexible support element. ({0080] lines 1-5; specifically, Vitale teaches the electrode made with a substrate infused with conductive ink).
Regarding claim 32, Vitale teaches: The electrode according to claim 31. Vitale further teaches: wherein each of said branches are arranged in a coplanar manner and converge with the tail parts thereof towards a terminal end (Figure 11 A; specifically, Vitale teaches the construction of the electrodes in a coplanar manor), and wherein each of the branches are further arranged symmetrically with respect to a plane perpendicular to the plane of coplanarity. (Figure 3 which shows that the branches are arranged in such a manner).
Claim Rejections - 35 USC § 103
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Vitale.
Claims 13 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Vitale in view of Ouyang et al. (US 20240400823 A1) herein referred to as “Ouyang”.
Regarding claim 13, Vitale discloses: the electrode according to claim 11. While Vitale does disclose the use of conductive material with in a rubber for the cup element as described above and using graphite as the elastomer particles as a conductive element within a substrate (claim 2), Vitale does not explicitly disclose: wherein said cup element includes conductive thermoplastic material, the conductive thermoplastic material comprising a thermoplastic elastomer
However, Ouyang discloses: wherein said cup element includes conductive thermoplastic material, the conductive thermoplastic material comprising a thermoplastic elastomer ([0057] lines 1-3 Ouyang teaches a conductive polymer in an elastomer and [0068] Ouyang teaches that elastomers are seen as thermoplastics).
It would have been obvious before effective filling date of the claimed invention to a person having ordinary skill in the art to modify the electrode cup as described in Vitale to include elastomer embedded with conductive polymer as disclosed in Ouyang. The motivation being that the disclosed elastomer has high conductivity, high mechanical stretchability, excellent adhesive to skin and excellent biocompatibility. (Ouyang [0037] lines 1-2). Further, it is substituting a known substrate rubber with conductive element (platinum) and utilizing another known substrate of a thermoplastic with conductive elements and it would result in the electrode still conducting electricity.
Regarding claim 29, Vitale discloses: the electrode according to claim 28. While Vitale does disclose the use of conductive material with in a rubber for the cup element as described above and using graphite as the elastomer particles as a conductive element within a substrate (claim 2), Vitale does not explicitly disclose: wherein said cup element includes conductive thermoplastic material, the conductive thermoplastic material comprising a thermoplastic elastomer
However, Ouyang discloses: wherein said cup element includes conductive thermoplastic material, the conductive thermoplastic material comprising a thermoplastic elastomer ([0057] lines 1-3 Ouyang teaches a conductive polymer in an elastomer and [0068] Ouyang teaches that elastomers are seen as thermoplastics).
It would have been obvious before effective filling date of the claimed invention to a person having ordinary skill in the art to modify the electrode cup as described in Vitale to include elastomer embedded with conductive polymer as disclosed in Ouyang. The motivation being that the disclosed elastomer has high conductivity, high mechanical stretchability, excellent adhesive to skin and excellent biocompatibility. (Ouyang [0037] lines 1-2). Further, it is substituting a known substrate rubber with conductive element (platinum) and utilizing another known substrate of a thermoplastic with conductive elements and it would result in the electrode still conducting electricity.
Conclusion
THIS ACTION IS MADE FINAL. 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 CASEY GEORGE CHA whose telephone number is (571)272-0749. The examiner can normally be reached Monday-Friday 8:30-5:00.
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/CASEY GEORGE CHA/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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