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 Amendment
The amendment filed April 17th, 2026 has been entered. Claims 1-3, and 5-20 remain pending in the application. Applicant’s amendments to the claims have overcome the rejections previously set forth in the Non-Final Office Action mailed February 3rd, 2026.
Response to Arguments
Applicant’s arguments with respect to claims 1-3 and 5-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-7, 12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pushpala et al. (US 2017/0128009 A1) herein referred to as “Pushpala” in view of Stemme et al. (US 2004/0054393 A1) herein referred to as “Stemme” further in view of Kendall et al. (US 20220346679 A1) herein referred to as “Kendall”.
Regarding claim 1, Pushpala discloses an electrode assembly structured for use in detecting electrodermal activity (EDA) (a subarray of the array of filaments 117 van also be used to detect other physiologically relevant parameters, including one or more of: electrophysiological signals, galvanic skin response (also known as electrodermal activity), Paragraph [0030]), the assembly comprising: a substrate (substrate, see modified Figure 1A below); at least two separate electrodes affixed to the substrate (at least two separate electrodes 120, see modified Figure 1A below);
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and a separate electrically-conductive coating covering each electrode (coating for each electrode, Figures 2A-2F), each electrically-conductive coating including: a base portion (base portion 130, Figures 2A-2F); and a plurality of unit cells extending from the base portion (unit cells (protrusions 130) extend from the base portion 130, Figures 2A-2F).
However Pushpala does not explicitly disclose wherein the base portion has a uniform thickness.
Stemme discloses a medical electrode with a plurality of spikes (Abstract) wherein the bas portion has a uniform thickness (bases of spikes 12 are joined to carrier base member 14 in a spaced array on the front side of the base member, Figures 4B and 4C, Paragraph [0030]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala to incorporate the teachings of Stemme by including wherein the base portion has a uniform thickness. The motivation to do so being that the base member is planar for the spikes to uniformly protrude from (Stemme, Paragraph [0012]).
However Pushpala in view of Stemme does not explicitly disclose wherein each unit cell including a straight pointed contact edge.
Kendall discloses a microelectrode system for detecting analytes (Abstract) wherein the device comprises unit comprising a straight pointed edge (the microstructure is a plate having a body 512.1 and a tip 512.2 which is tapered to facilitate penetration of the microstructure 512 into the stratum corneum, Paragraphs [0503]-[0504], Figures 5A to 5D).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala in view of Stemme to incorporate the teachings of Kendall by including wherein each unit cell including a straight pointed contact edge. The motivation to do so being to facilitate penetration of the stratum corneum for measuring signals (Kendall, Paragraph [0503]).
Regarding claim 2, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 1.
Pushpala further discloses wherein the unit cells of the plurality of unit cells are spaced apart equidistantly (unit cells are equidistant from each other, Figures 2A, 2E, 5B and 5C).
Regarding claim 3, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 1.
Pushpala further discloses wherein the unit cells of the plurality of unit cells extend perpendicularly from the base portion of the coating (unit cells 130 extend perpendicularly from the coating base portion, see modified Figure 2E below).
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Regarding claim 5, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 1.
Pushpala further discloses wherein the plurality of unit cells, in combination, form an overall microstructure supported by the base portion of the coating (array of sharp protrusions (seen as the microstructure, which is supported by the coating base portion), Figure 5C, Paragraph [0053]).
Regarding claim 6, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 1.
Pushpala further discloses wherein each unit cell of the plurality of unit cells comprises: a first flat surface extending at a first angle with respect to a first reference plane extending perpendicularly with respect to the base portion of an associated coating (see modified Figure 5C below, first angle is aligned with first reference plane);
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and a second flat surface positioned opposite the first flat surface and extending at a second angle with respect to a second reference plane extending perpendicularly with respect to the base portion of an associated coating (see modified Figure 5C below, second angle is with respect to the second reference plane (angled inwards towards the first flat surface away from the second reference plane)).
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Regarding claim 7, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 6.
Pushpala further discloses wherein each unit cell of the plurality of unit cells further comprises: a third flat surface extending at a third angle with respect to a third reference plane extending perpendicularly with respect to the base portion of an associated coating and orthogonally with respect to the first reference plane (see modified Figure 5C below, third angle is with respect to the third reference plane (angled inwards away from third reference plane));
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and a fourth flat surface positioned opposite the third flat surface and extending at the third angle with respect a fourth reference plane extending perpendicularly with respect to the base portion of an associated coating and orthogonally with respect to the first reference plane (see modified Figure 5C below, fourth angle is with respect to the fourth reference plane (angled inwards towards third flat surface away from fourth reference plane)).
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Regarding claim 12, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 1.
Pushpala further discloses wherein each unit cell of the plurality of unit cells has an associated height (each unit cell has an associated height, Figures 2A-2F, and 5C), and wherein heights of the unit cells of the plurality of unit cells are equal (heights of unit cells are equal, see array in Figure 5C).
Regarding claim 17, Pushpala in view of Stemme and Kendall discloses the electrode assembly in accordance with claim 1.
Pushpala further discloses wherein the device is an electrodermal activity sensor including an electrode assembly (microsensor, Figures 1A, 2A, and 2B, Paragraph [0025]).
Claims 8-9, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pushpala in view of Stemme and Kendall further in view of Connor (US 11850052 B2) herein referred to as “Connor”.
Regarding claim 8, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 1.
Pushpala further discloses wherein each unit cell contact edge has an associated width (each contact edge has an associated width, see Figures 2A-2F and 5C).
However Pushpala in view of Stemme and Kendall does not explicitly disclose wherein at least a portion of the unit cells are arranged so that contact edge widths of successive unit cells proceeding in a direction along a plane perpendicular to the base portion of an associated coating decrease from a relatively greater width to a relatively lesser width.
Connor discloses an EEG electrode comprising a plurality of articulated conductive protrusions (Abstract) wherein at least a portion of the unit cells are arranged so that contact edge widths of successive unit cells proceeding in a direction along a first plane perpendicular to the base portion of an associated coating decrease from a relatively greater width to a relatively lesser width (Figure 50 shows a distal electrode base 5001, and a plurality of electroconductive protrusions (seen as unit cells) including protrusions 5002, 5003, 5004, and 5005, wherein a first protrusion has a first width and a second protrusion has a second width and a third protrusion has a third width, wherein the second width is different from the first width and the third width is different from the second width, in this example, the second width is greater than the first width and the third width is greater than the second width (i.e., the contact edges decrease from a greater width from the edge of the electrode to a less width in the center of the electrode), Col. 95, lines 36-56, Figure 50).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala in view of Stemme and Kendall to incorporate the teachings of Connor by including wherein at least a portion of the unit cells are arranged so that contact edge widths of successive unit cells proceeding in a direction along a first plane perpendicular to the base portion of an associated coating decrease from a relatively greater width to a relatively lesser width. The motivation to do so being to penetrate between hairs and come into contact with the surface of the person’s head (Connor, Col. 95, lines 41-44).
Regarding claim 9, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 8.
However Pushpala in view of Stemme and Kendall does not explicitly disclose wherein at least a portion of the unit cells are arranged so that contact edge widths of successive unit cells proceeding in a direction along a second plane perpendicular to the base portion and to the first plane increase from a relatively lesser width to a relatively greater width.
Connor discloses an EEG electrode comprising a plurality of articulated conductive protrusions (Abstract) wherein at least a portion of the unit cells are arranged so that contact edge widths of successive unit cells proceeding in a direction along a second plane perpendicular to the base portion and to the first plane increase from a relatively lesser width to a relatively greater width (Figure 50 shows a distal electrode base 5001, and a plurality of electroconductive protrusions (seen as unit cells) including protrusions 5002, 5003, 5004, and 5005, wherein a first protrusion has a first width and a second protrusion has a second width and a third protrusion has a third width, wherein the second width is different from the first width and the third width is different from the second width, in an alternative example, the second width can be less than the first width and the third width can be less than the second width (i.e., the center protrusion contact edge has a lesser width and the size of the contact edge increases from the center protrusion to a greater contact edge width towards the edge of the electrode), Col. 95, lines 36-56, Figure 50).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala in view of Stemme and Kendall to incorporate the teachings of Connor by including wherein at least a portion of the unit cells are arranged so that contact edge widths of successive unit cells proceeding in a direction along a second plane perpendicular to the base portion and to the first plane increase from a relatively lesser width to a relatively greater width. The motivation to do so being to penetrate between hairs and come into contact with the surface of the person’s head (Connor, Col. 95, lines 41-44).
Regarding claim 10, Pushpala in view of Stemme, Kendall, and Connor discloses the electrode assembly of claim 8.
However Pushpala in view of Stemme and Kendall does not explicitly disclose wherein the contact edges of the unit cells extend parallel to the base portion.
Kendall discloses wherein the contact edges of the unit cells extend parallel to the base portion (the straight edge contact edges extend parallel to the base portion of the device, Paragraphs [0503]-[0504], Figure 5D).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala in view of Stemme, Kendall, and Connor to incorporate the teachings of Kendall by including wherein the contact edges of the unit cells extend parallel to the base portion. The motivation to do so being to facilitate penetration of the stratum corneum for measuring signals (Kendall, Paragraph [0503]).
Regarding claim 13, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 1.
However Pushpala in view of Stemme and Kendall does not explicitly disclose wherein each unit cell of the plurality of unit cells comprises a cylindrical bottom portion operably connecting the unit cell with the base portion of an associated coating, each unit cell bottom portion having an associated equal diameter.
Connor discloses wherein each unit cell of the plurality of unit cells comprises a cylindrical bottom portion operably connecting the unit cell with the base portion of an associated coating (see Figures 1, 38, 39 and 40), wherein each unit cell bottom portion has an associated equal diameter (each protrusion has an associated width (diameter), each protrusion is equal in diameter, Figures 1, 38, 39, 40).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala in view of Stemme and Kendall to incorporate the teachings of Connor by including wherein each unit cell of the plurality of unit cells comprises a cylindrical bottom portion operably connecting the unit cell with the base portion of an associated coating, each unit cell bottom portion having an associated equal diameter. The motivation to do so being to include protrusions that penetrate between hairs and come into contact with the surface of the person’s head (Connor, Col. 58, lines 4-15).
Regarding claim 14, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 1.
Pushpala further discloses wherein each unit cell contact edge has an associated width, wherein contact edges of the unit cells extend parallel to each other (each contact edge has an associated width and the contact edges are parallel to each other (Figure 1A and 5C), see Figures 2A-2F and 5C).
However Pushpala in view of Stemme and Kendall does not explicitly disclose wherein each unit cell comprises a cylindrical bottom portion operably connecting the unit cell with the coating base portion, wherein each unit cell bottom portion has an associated diameter, and wherein at least a portion of the unit cells are arranged so that diameters of successive unit cell bottom portions proceeding in a direction along a first plane perpendicular to the coating base portion decrease from a relatively greater diameter to a relatively lesser diameter.
Connor discloses wherein each unit cell comprises a cylindrical bottom portion operably connecting the unit cell with the coating base portion (see Figures 1, 38, 39 and 40), wherein each unit cell bottom portion has an associated diameter (each protrusion has an associated width (diameter), Col. 95, lines 44-56), and wherein at least a portion of the unit cells are arranged so that diameters of successive unit cell bottom portions proceeding in a direction along a first plane perpendicular to the coating base portion decrease from a relatively greater diameter to a relatively lesser diameter (Figure 50 shows a distal electrode base 5001, and a plurality of electroconductive protrusions (seen as unit cells) including protrusions 5002, 5003, 5004, and 5005, wherein a first protrusion has a first width and a second protrusion has a second width and a third protrusion has a third width, wherein the second width is different from the first width and the third width is different from the second width, in this example, the second width is greater than the first width and the third width is greater than the second width (i.e., the contact edges decrease from a greater diameter from the edge of the electrode to a less diameter in the center of the electrode), Col. 95, lines 36-56, Figure 50).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala in view of Stemme and Kendall to incorporate the teachings of Connor by including wherein each unit cell comprises a cylindrical bottom portion operably connecting the unit cell with the coating base portion, wherein each unit cell bottom portion has an associated diameter, and wherein at least a portion of the unit cells are arranged so that diameters of successive unit cell bottom portions proceeding in a direction along a first plane perpendicular to the coating base portion decrease from a relatively greater diameter to a relatively lesser diameter. The motivation to do so being to penetrate between hairs and come into contact with the surface of the person’s head (Connor, Col. 95, lines 41-44).
Regarding claim 15, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 1.
Pushpala further discloses wherein each unit cell contact edge has an associated width, wherein contact edges of the unit cells extend parallel to each other (each contact edge has an associated width and the contact edges are parallel to each other (Figure 1A and 5C), see Figures 2A-2F and 5C).
However Pushpala in view of Stemme and Kendall does not explicitly disclose wherein each unit cell comprises a cylindrical bottom portion operably connecting the unit cell with the base portion of an associated coating, wherein each unit cell bottom portion has an associated diameter, and wherein at least a portion of the unit cells are arranged so that diameters of successive unit cell bottom portions proceeding in a direction along a second plane perpendicular to the base portion and to the first plane increase from a relatively lesser diameter to a relatively greater diameter.
Connor discloses wherein each unit cell comprises a cylindrical bottom portion operably connecting the unit cell with the base portion of an associated coating (see Figures 1, 38, 39 and 40), wherein each unit cell bottom portion has an associated diameter (each protrusion has an associated width (diameter), Col. 95, lines 44-56), and wherein at least a portion of the unit cells are arranged so that diameters of successive unit cell bottom portions proceeding in a direction along a second plane perpendicular to the base portion and to the first plane increase from a relatively lesser diameter to a relatively greater diameter (Figure 50 shows a distal electrode base 5001, and a plurality of electroconductive protrusions (seen as unit cells) including protrusions 5002, 5003, 5004, and 5005, wherein a first protrusion has a first width and a second protrusion has a second width and a third protrusion has a third width, wherein the second width is different from the first width and the third width is different from the second width, in an alternative example, the second width can be less than the first width and the third width can be less than the second width (i.e., the center protrusion has a lesser diameter and the size of the diameters of the protrusions increases from the center protrusion to a greater diameter protrusion towards the edge of the electrode), Col. 95, lines 36-56, Figure 50).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala in view of Stemme and Kendall to incorporate the teachings of Connor by including wherein each unit cell comprises a cylindrical bottom portion operably connecting the unit cell with the base portion of an associated coating, wherein each unit cell bottom portion has an associated diameter, and wherein at least a portion of the unit cells are arranged so that diameters of successive unit cell bottom portions proceeding in a direction along a second plane perpendicular to the base portion and to the first plane increase from a relatively lesser diameter to a relatively greater diameter. The motivation to do so being to penetrate between hairs and come into contact with the surface of the person’s head (Connor, Col. 95, lines 41-44).
Claims 11 are rejected under 35 U.S.C. 103 as being unpatentable over Pushpala in view of Stemme and Kendall further in view of Rood et al. (US 8201330 B1) herein referred to as “Rood”.
Regarding claim 11, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 1.
Pushpala further discloses wherein each unit cell of the plurality of unit cells has an associated height (each unit cell has an associated height, Figures 2A-2F, and 5C).
However Pushpala in view of Stemme and Kendall does not explicitly disclose wherein at least a portion of the unit cells are arranged so that heights of successive unit cells proceeding in a direction along a flat plane extending perpendicular to the base portion of an associated coating increase from a relatively lesser height to a relatively greater height.
Rood discloses a physiological recording electrode (Abstract) wherein at least a portion of the unit cells are arranged so that heights of successive unit cells proceeding in a direction along a flat plane extending perpendicular to the base portion of an associated coating increase from a relatively lesser height to a relatively greater height (the electrode 10 comprises a substrate 12 with a lower surface 13 comprising penetrators 16 wherein the penetrators increase from a relatively lesser height to a relatively greater height from the edge of the electrode to the center of the electrode along a flat plane perpendicular to the base portion 13, Figure 11, Col. 19, lines 60-67).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala in view of Stemme and Kendall to incorporate the teachings of Rood by including wherein at least a portion of the unit cells are arranged so that heights of successive unit cells proceeding in a direction along a flat plane extending perpendicular to the base portion of an associated coating increase from a relatively lesser height to a relatively greater height. The motivation to do so being to increase the amount of surface area of the skin in contact with the electrode (Rood, Col. 17, lines 46-60).
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Pushpala in view of Stemme and Kendall further in view of Lisy et al. (US 9192313 B1) herein referred to as “Lisy” as evidenced by “Technical Data Sheet for Silicon” and “Technical Data Sheet for Silver” (see attached documents).
Regarding claim 16, Pushpala in view of Stemme and Kendall discloses the electrode assembly of claim 1.
Pushpala discloses wherein the unit cells of the plurality of unit cells are formed from a same material (the substrate 130 is processed to form at least one protrusion (seen as the unit cells), wherein the substrate has a uniform composition, and can be composed of a semiconducting material, a conducting material, and/or an insulating or non-conductive material, Paragraph [0032]), wherein the material forming the unit cells has a first hardness (the substrate 130 can be formed of a semiconducting material such as silicon, wherein silicon has a first hardness, Paragraph [0032], (Mohs hardness of silicon is 6.5 (see attached Technical Data Sheet for silicon)), wherein each unit cell of the plurality of unit cells is spaced apart at least a predetermined distance from any adjacent unit cell so as to provide a gap therebetween (protrusions 130 are spaced apart at least a predetermined distance, Figures 2A, and 5C).
Pushpala does disclose the use of a material in the gap between each protrusion (biocompatible layer 185 to enhance biocompatibility of the filament 120, Figure 2E, Paragraph [0043]), however Pushpala in view of Stemme and Kendall does not explicitly disclose and wherein all gaps between adjacent unit cells are filled in with a conductive material having a second hardness less than the first hardness.
Lisy discloses a physiological recording device used for recording signals on a user’s skin (Abstract) wherein all gaps between adjacent unit cells are filled in with a conductive material having a second hardness less than the first hardness (surface features 102 are penetrators (seen as unit cells), Col. 25, lines 49-51, wherein the gaps between surface features 102 are with a conductive material 104 which can be made of silver/silver chloride (Ag/AgCl), Col. 25, lines 34-39, Figures 1C and 2E, (Mohs hardness scale of silver is 2.5 (see attached Technical Data Sheet for silver)).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala in view of Stemme and Kendall to incorporate the teachings of Lisy by including wherein all gaps between adjacent unit cells are filled in with a conductive material having a second hardness less than the first hardness. The motivation to do so being to minimize electrical impedance and provide a conductive electrical pathway for biopotentials to be transmitted from the lower layers of the patient’s skin to the monitoring equipment (Lisy, Col. 25, lines 39-46).
Regarding claim 19, Pushpala in view of Stemme, Kendall, and Lisy discloses the electrode assembly of claim 16.
Pushpala discloses wherein contact edges of the unit cells are uncovered by a conductive material (Figure 2A).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala in view of Stemme, Kendall, and Lisy to incorporate the teachings of Pushpala by including wherein contact edges of the unit cells are uncovered by a conductive material. The motivation to do so being to sense specific target analytes/ions characterizing the user’s body chemistry (Pushpala, Paragraph [0031]).
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pushpala in view of Stemme and Kendall further in view of Lisy et al. (US 9192313 B1) herein referred to as “Lisy” as evidenced by “Technical Data Sheet for Silicon” and “Technical Data Sheet for Silver” (see attached documents) further in view of Kendall.
Regarding claim 18, Pushpala discloses an electrode assembly structured for use in detecting electrodermal activity (EDA) (a subarray of the array of filaments 117 van also be used to detect other physiologically relevant parameters, including one or more of: electrophysiological signals, galvanic skin response (also known as electrodermal activity), Paragraph [0030]), the assembly comprising: a substrate (substrate, see modified Figure 1A below); at least two separate electrodes affixed to the substrate (at least two separate electrodes 120, see modified Figure 1A below);
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a separate electrically conductive coating covering each electrode (coating for each electrode, Figures 2A-2F), each electrically-conductive coating including: a base portion (base portion 130, Figures 2A-2F); and a plurality of unit cells extending from the base portion (unit cells (protrusions 130) extend from the base portion 130, Figures 2A-2F), all of the unit cells being formed from a same material (the substrate 130 is processed to form at least one protrusion (seen as the unit cells), wherein the substrate has a uniform composition, and can be composed of a semiconducting material, a conducting material, and/or an insulating or non-conductive material, Paragraph [0032]), the material forming the unit cells having a first hardness (the substrate 130 can be formed of a semiconducting material such as silicon, wherein silicon has a first hardness, Paragraph [0032], (Mohs hardness of silicon is 6.5 (see attached Technical Data Sheet for silicon)), wherein each unit cell is spaced apart at least a predetermined distance from any adjacent unit cell so as to provide a gap therebetween (protrusions 130 are spaced apart at least a predetermined distance, Figures 2A, and 5C).
Pushpala does disclose the use of a material in the gap between each protrusion (biocompatible layer 185 to enhance biocompatibility of the filament 120, Figure 2E, Paragraph [0043]), however Pushpala does not explicitly disclose and wherein all gaps between adjacent unit cells are filled in with a conductive material having a second hardness less than the first hardness.
Lisy discloses a physiological recording device used for recording signals on a user’s skin (Abstract) wherein all gaps between adjacent unit cells are filled in with a conductive material having a second hardness less than the first hardness (surface features 102 are penetrators (seen as unit cells), Col. 25, lines 49-51, wherein the gaps between surface features 102 are with a conductive material 104 which can be made of silver/silver chloride (Ag/AgCl), Col. 25, lines 34-39, Figures 1C and 2E, (Mohs hardness scale of silver is 2.5 (see attached Technical Data Sheet for silver)).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala to incorporate the teachings of Lisy by including wherein all gaps between adjacent unit cells are filled in with a conductive material having a second hardness less than the first hardness. The motivation to do so being to minimize electrical impedance and provide a conductive electrical pathway for biopotentials to be transmitted from the lower layers of the patient’s skin to the monitoring equipment (Lisy, Col. 25, lines 39-46).
However Pushpala in view of Lisy does not explicitly disclose wherein each unit cell including a straight pointed contact edge.
Kendall discloses a microelectrode system for detecting analytes (Abstract) wherein the device comprises unit comprising a straight pointed edge (the microstructure is a plate having a body 512.1 and a tip 512.2 which is tapered to facilitate penetration of the microstructure 512 into the stratum corneum, Paragraphs [0503]-[0504], Figures 5A to 5D).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala in view of Lisy to incorporate the teachings of Kendall by including wherein each unit cell including a straight pointed contact edge. The motivation to do so being to facilitate penetration of the stratum corneum for measuring signals (Kendall, Paragraph [0503]).
Regarding claim 20, Pushpala discloses an electrode assembly structured for use in detecting electrodermal activity (EDA) (a subarray of the array of filaments 117 van also be used to detect other physiologically relevant parameters, including one or more of: electrophysiological signals, galvanic skin response (also known as electrodermal activity), Paragraph [0030]), the assembly comprising: a substrate (substrate, see modified Figure 1A below); at least two separate electrodes affixed to the substrate (at least two separate electrodes 120, see modified Figure 1A below);
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and a separate electrically-conductive coating covering each electrode (coating for each electrode, Figures 2A-2F), each electrically-conductive coating including: a base portion (base portion 130, Figures 2A-2F); and a plurality of unit cells extending from the base portion (unit cells (protrusions 130) extend from the base portion 130, Figures 2A-2F), wherein the unit cells are formed from a same material (the substrate 130 is processed to form at least one protrusion (seen as the unit cells), wherein the substrate has a uniform composition, and can be composed of a semiconducting material, a conducting material, and/or an insulating or non-conductive material, Paragraph [0032]), wherein the material forming the unit cells has a first hardness (the substrate 130 can be formed of a semiconducting material such as silicon, wherein silicon has a first hardness, Paragraph [0032], (Mohs hardness of silicon is 6.5 (see attached Technical Data Sheet for silicon)), wherein each unit cell is spaced apart at least a predetermined distance from any adjacent unit cell so as to provide a gap therebetween (protrusions 130 are spaced apart at least a predetermined distance, Figures 2A, and 5C).
Pushpala does disclose the use of a material in the gap between each protrusion (biocompatible layer 185 to enhance biocompatibility of the filament 120, Figure 2E, Paragraph [0043]), however Pushpala does not explicitly disclose and wherein all gaps between adjacent unit cells are filled in with a conductive material having a second hardness less than the first hardness.
Lisy discloses a physiological recording device used for recording signals on a user’s skin (Abstract) wherein all gaps between adjacent unit cells are filled in with a conductive material having a second hardness less than the first hardness (surface features 102 are penetrators (seen as unit cells), Col. 25, lines 49-51, wherein the gaps between surface features 102 are with a conductive material 104 which can be made of silver/silver chloride (Ag/AgCl), Col. 25, lines 34-39, Figures 1C and 2E, (Mohs hardness scale of silver is 2.5 (see attached Technical Data Sheet for silver)).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala to incorporate the teachings of Lisy by including wherein all gaps between adjacent unit cells are filled in with a conductive material having a second hardness less than the first hardness. The motivation to do so being to minimize electrical impedance and provide a conductive electrical pathway for biopotentials to be transmitted from the lower layers of the patient’s skin to the monitoring equipment (Lisy, Col. 25, lines 39-46).
However Pushpala in view of Lisy does not explicitly disclose wherein each unit cell including a straight pointed contact edge.
Kendall discloses a microelectrode system for detecting analytes (Abstract) wherein the device comprises unit comprising a straight pointed edge (the microstructure is a plate having a body 512.1 and a tip 512.2 which is tapered to facilitate penetration of the microstructure 512 into the stratum corneum, Paragraphs [0503]-[0504], Figures 5A to 5D).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pushpala in view of Lisy to incorporate the teachings of Kendall by including wherein each unit cell including a straight pointed contact edge. The motivation to do so being to facilitate penetration of the stratum corneum for measuring signals (Kendall, Paragraph [0503]).
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.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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