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
Claims 1-16 and 18-22 remain pending.
Response to Arguments
Applicant's arguments filed 12/02/2025 have been fully considered but they are not persuasive.
Regarding claim 1, Pieri teaches a surface electrode comprising both a dry electrode plate ([0032] the substrate 100 may further be shaped to provide for a plurality of sensors, including, and in addition to electrodes 1-5) ([0033] The electrodes 1-5 and/or the conducting tracks 15 and/or the auxiliary sensor 18 are formed from the signal layer 12, which includes silver ink or another material with the electrical and/or mechanical properties to form a sensor in the signal layer. For example, the conducting film used can be silver chloride which provides a good stoichiometric match to saline based electrode gels. A silver-containing ink may be used in particular to print the conducting tracks 15 and/or signal layer 12) ([0033] the auxiliary sensor 18 may be a separately formed component and the signal layer 12 provides the conducting track 15 and/or a mounting or connection pad or contact) ([0040] patch regions 21-26 exemplarily corresponding with each sensor. These sensors may include electrodes 1-5 and auxiliary sensor 1) and a wet electrode ([0040] For sensors of the plurality of sensors for which a conductive connection between the sensor and the skin of the maternal patient is needed, a conducting medium (for example ECG or acoustic gel) is preferably disposed between the sensors and the skin of the subject, thereby signally coupling the sensors to the skin of the maternal patient); a multi-electrode patch containing a plurality of surface electrodes each comprising both a dry electrode plate and a wet electrode (Fig 1).
Cross teaches first wet electrode 28 and dry electrode 32 comprising of silver/silver chloride or other suitable material ([0041]).
Further, Barry teaches a conductive epoxy between the dry electrode plate and the
wet electrode and configured to protect the dry electrode plate from corrosion ([0301] contact 212b may comprise silver and silver chloride and contact 334 may comprise gold, nickel, and copper. It is contemplated that the galvanic interaction between gold and silver/silver chloride or copper and silver/silver chloride may result in corrosion of contact 334. Thus, filling in the space between contact 334 and contact 212b with conductive epoxy 2122 may reduce corrosion of contact 334). It is acknowledged that Barry discloses preventing corrosion with a specific metal interaction, however this does not mean the teachings of the conductive epoxy by Barry wouldn't motivate someone to use the epoxy to prevent corrosion with other suitable metal materials.
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.
Claim(s) 1, 3, 7, 9-13, 15, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pieri (WO 2020214812 A1) in view of Cross (US 20080288026 A1) and Barry (US 20200330036 A1).
Regarding claim 1, Pieri teaches a surface electrode for patient monitoring comprising: a flexible substrate ([0032] The patch 150 includes a flexible substrate 100); a dry electrode plate on a sensor region of the flexible substrate ([0032] the substrate 100 may further be shaped to provide for a plurality of sensors, including, and in addition to electrodes 1-5) ([0033] The electrodes 1-5 and/or the conducting tracks 15 and/or the auxiliary sensor 18 are formed from the signal layer 12, which includes silver ink or another material with the electrical and/or mechanical properties to form a sensor in the signal layer. For example, the conducting film used can be silver chloride which provides a good stoichiometric match to saline based electrode gels. A silver-containing ink may be used in particular to print the conducting tracks 15 and/or signal layer 12) ([0033] the auxiliary sensor 18 may be a separately formed component and the signal layer 12 provides the conducting track 15 and/or a mounting or connection pad or contact) ([0040] patch regions 21-26 exemplarily corresponding with each sensor. These sensors may include electrodes 1-5 and auxiliary sensor 1), wherein the dry electrode plate is configured to obtain electrophysiological signals from a patient ([0030] The controller 306 may be any of a variety of controllers, microcontrollers, processors, or integrated circuits as known in the art of physiological sensing for collection and/or analysis of physiological data); a wet electrode configured to contact an electrode gel in contact with a patient's skin ([0040] For sensors of the plurality of sensors for which a conductive connection between the sensor and the skin of the maternal patient is needed, a conducting medium (for example ECG or acoustic gel) is preferably disposed between the sensors and the skin of the subject, thereby signally coupling the sensors to the skin of the maternal patient), and to transfer electrical potentials from the wet electrode to the dry electrode plate ([0028] These electrical property sensors 302 collect biopotentials from the skin of the maternal patient, which include biopotential signals from both the maternal and fetal patients).
Pieri fails to fully teach a conductive epoxy arranged between the dry electrode and the wet electrode, the conductive epoxy configured to protect the dry electrode from corrosion. However, Cross teaches a conductive epoxy arranged between the dry electrode and the wet electrode (Fig 6; [0053] adhesive layer 104 include respective openings 60, 106 to be filled with conductive epoxy 107). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include a conductive epoxy arranged between the dry electrode and the wet electrode. Doing so allows the wet electrode to be in contact to the dry electrode.
Further, Barry teaches the conductive epoxy configured to protect the dry electrode plate from corrosion ([302] filling in the space between contact 334 and contact 212b with conductive epoxy 2122 may reduce corrosion of contact 334). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include the conductive epoxy configured to protect the dry electrode plate from corrosion. Doing so for the wet electrode gel to be in contact to the dry electrode without the risk of corrosion.
Regarding claim 3, Pieri teaches the surface electrode of claim 1, but fails to fully teach wherein the conductive epoxy is deposited on a top surface of the dry electrode between the dry electrode and the wet electrode. However, Cross teaches wherein the conductive epoxy is deposited on a top surface of the dry electrode between the dry electrode and the wet electrode (Fig 6; [0053] adhesive layer 104 include respective openings 60, 106 to be filled with conductive epoxy 107). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the conductive epoxy is deposited on a top surface of the dry electrode between the dry electrode and the wet electrode. Doing so allows for electrical potentials to be transferred from the wet to dry electrode for sensing signals.
Regarding claim 7, Pieri teaches the surface electrode of claim 3, but fails to fully teach wherein the conductive epoxy is in contact with the wet electrode. However, cross teaches wherein the conductive epoxy is in contact with the wet electrode (Fig 6; [0053] adhesive layer 104 include respective openings 60, 106 to be filled with conductive epoxy 107). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the conductive epoxy is in contact with the wet electrode. Doing so allows for electrical potentials to be transferred from the wet to dry electrode for sensing signals.
Regarding claim 9, Pieri teaches the surface electrode of claim 1, but fails to fully teach wherein the wet electrode comprises a sponge impregnated with the electrode gel. However, Cross teaches wherein the wet electrode comprises a sponge impregnated with the electrode gel ([0078] To ensure a consistent seal, a thicker PSA layer, or a thin (20 mil or 32-mil) PE or PU foam with adhesive on both sides may be used in place of the thick PSA. Being compressible, the foam compensates well for variations of Ag/AgCl post protrusion distances). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the wet electrode comprises a sponge impregnated with the electrode gel. Doing so allows for a secure surface connection of the gel to the skin for biosensing.
Regarding claim 10, Pieri teaches the surface electrode of claim 1, but fails to fully teach wherein the electrode gel is a sodium chloride gel or a potassium chloride gel. However, Cross teaches wherein the electrode gel is a sodium chloride gel or a potassium chloride gel ([0043] Typical components of a conductive hydrogel include water, which acts as the solvent, water-soluble monomers, which crosslink to give structure to the gel and which may also provide skin adhesion, humectant materials which reduce the dryout characteristics of the hydrogel material, and electrolytes or salts such as sodium chloride or potassium chloride dissolved in water, which provide and facilitate ionic movement and conductivity). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the electrode gel is a sodium chloride gel or a potassium chloride gel. Doing so provides and facilitates ionic movement and conductivity between the electrode and the skin.
Regarding claim 11, Pieri teaches the surface electrode of claim 1, wherein the dry electrode comprises silver ([0032] the substrate 100 may further be shaped to provide for a plurality of sensors, including, and in addition to electrodes 1-5) ([0033] The electrodes 1-5 and/or the conducting tracks 15 and/or the auxiliary sensor 18 are formed from the signal layer 12, which includes silver ink or another material with the electrical and/or mechanical properties to form a sensor in the signal layer).
Regarding claim 12, Pieri teaches the surface electrode of claim 1, wherein the wet electrode comprises silver/silver- chloride ([0033] the conducting film used can be silver chloride which provides a good stoichiometric match to saline based electrode gels).
Regarding claim 13, Pieri teaches a multi-electrode patch for detecting electrophysiological signals ([0030] The controller 306 may be any of a variety of controllers, microcontrollers, processors, or integrated circuits as known in the art of physiological sensing for collection and/or analysis of physiological data), the multi- electrode patch comprising (Fig 2; electrodes 1-5): a flexible substrate ([0032] The patch 150 includes a flexible substrate 100); a plurality of surface electrodes (Fig 2; electrodes 1-5) and a plurality of leadwires (Fig 2; conducting tracks 15) printed on the flexible substrate ([0033] A silver-containing ink may be used in particular to print the conducting tracks 15 and/or signal layer 12), wherein each of the plurality of surface electrodes comprising: a printed dry electrode plate printed on the flexible substrate ([0014] The plurality of electrodes, the conductive layer, and the at least one mechanical motion sensor may be printed from conductive ink) ([0032] The layers 6-12 are patterned so as to define the shape of the substrate 100, and to form electrodes 1-5. Each electrode 1-5 is connected via a conducting track 15 to a connection hub 16, for electrically connecting electrodes 1-5 to a readout device (not shown)) and connected to one of the plurality of leadwires ([0032] Each electrode 1-5 is connected via a conducting track 15 to a connection hub 16); wherein the dry electrode plate is configured to obtain electrophysiological signals from a patient ([0030] The controller 306 may be any of a variety of controllers, microcontrollers, processors, or integrated circuits as known in the art of physiological sensing for collection and/or analysis of physiological data); a wet electrode configured to contact an electrode gel in contact with a patient's skin (([0040] For sensors of the plurality of sensors for which a conductive connection between the sensor and the skin of the maternal patient is needed, a conducting medium (for example ECG or acoustic gel) is preferably disposed between the sensors and the skin of the subject, thereby signally coupling the sensors to the skin of the maternal patient); and transfer electrical potentials from the wet electrode to the printed dry electrode plate ([0028] These electrical property sensors 302 collect biopotentials from the skin of the maternal patient, which include biopotential signals from both the maternal and fetal patients).
Pieri fails to fully teach a conductive epoxy arranged between the printed dry electrode plate and the wet electrode; the conductive epoxy configured to protect the printed dry electrode plate from corrosion.
However, Cross teaches a conductive epoxy arranged between the dry electrode and the wet electrode (Fig 6; [0053] adhesive layer 104 include respective openings 60, 106 to be filled with conductive epoxy 107). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include the conductive epoxy arranged between the dry electrode and the wet electrode. Doing so allows the wet electrode to be in contact to the dry electrode.
Further, Barry teaches the conductive epoxy configured to protect the dry electrode plate from corrosion ([302] filling in the space between contact 334 and contact 212b with conductive epoxy 2122 may reduce corrosion of contact 334). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include the conductive epoxy configured to protect the dry electrode plate from corrosion. Doing so allows for the wet electrode gel to be in contact to the dry electrode without the risk of corrosion.
Regarding claim 15, Pieri teaches the multi-electrode patch of claim 13, but fails to fully teach wherein the conductive epoxy is deposited on a top surface of the printed dry electrode between the dry electrode and the wet electrode. However, Cross teaches wherein the conductive epoxy is deposited on a top surface of the printed dry electrode between the dry electrode and the wet electrode (Fig 6; [0053] adhesive layer 104 include respective openings 60, 106 to be filled with conductive epoxy 107). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the conductive epoxy is deposited on a top surface of the printed dry electrode between the dry electrode and the wet electrode. Doing so allows for the wet electrode gel to be in contact to the dry electrode without the risk of corrosion.
Regarding claim 20, Pieri teaches wherein the printed dry electrode plate comprises silver ([0032] the substrate 100 may further be shaped to provide for a plurality of sensors, including, and in addition to electrodes 1-5) ([0033] The electrodes 1-5 and/or the conducting tracks 15 and/or the auxiliary sensor 18 are formed from the signal layer 12, which includes silver ink or another material with the electrical and/or mechanical properties to form a sensor in the signal layer) and the wet electrode comprises silver/silver-chloride ([0033] the conducting film used can be silver chloride which provides a good stoichiometric match to saline based electrode gels).
Regarding claim 21, Pieri teaches the multi-electrode patch of claim 13, wherein each of the surface electrodes is printed on a separate sensor region of the flexible substrate ([0036] these include placing the auxiliary sensor 18 in one or more of the patch regions 21-25 which contain the electrodes 1-5, in a central patch region 20 of the substrate, or in a dedicated sensor patch region 26 of the substrate 100) and each lead wire is printed on a respective connecting section connecting each sensor region to a hub (Fig 2; [0032] Each electrode 1-5 is connected via a conducting track 15 to a connection hub 16, for electrically connecting electrodes 1-5 to a readout device (not shown)).
Regarding claim 22, Pieri teaches the surface electrode of claim 1, wherein the dry electrode is substantially the same diameter as the wet electrode ([0032] The flexible substrate 100 comprises a plurality of layers 6-12. The layers 6-12 are patterned so as to define the shape of the substrate 100, and to form electrodes 1-5) ([0040] it will be recognized that the sensors may be arranged in any shape as is suitable for the measurement obtained by such sensors. The patch regions 21-26 extend about the respective sensors associated therein).
Claim(s) 2, 4-6, 8, 14, 16, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pieri (WO 2020214812 A1) in view of Cross (US 20080288026 A1) and Barry (US 20200330036 A1), further in view of Finneran (WO 0019892 A1).
Regarding claim 2, Pieri teaches the surface electrode of claim 1, but fails to teach wherein the conductive epoxy is a silver-based epoxy. However, Finneran teaches wherein the conductive epoxy is a silver-based epoxy ([Page 23, line 1-5] Figure 44 is representative of a cross sectional view of the flexible electrode aπay 302. In this described exemplary embodiment each electrode 304 is silk screen printed on the substrate 306 with a highly conductive printing material such as a silver/silver chloride epoxy ink). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the conductive epoxy is a silver-based epoxy. Doing so creates a highly conductive epoxy for use with electrodes.
Regarding claim 4, Pieri teaches the surface electrode of claim 3, but fails to teach wherein the conductive epoxy is a continuous layer covering the entire top surface of the dry electrode. However, Finneran teaches wherein the conductive epoxy is a continuous layer covering the entire top surface of the dry electrode (Fig 44; epoxy ink layer 310). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the conductive epoxy is a continuous layer covering the entire top surface of the dry electrode. Doing so covers the surface of the electrode for protection and longevity of the electrode piece while still providing conductivity.
Regarding claim 5, Pieri teaches the surface electrode of claim 3, but fails to teach wherein the conductive epoxy extends around the sides of the dry electrode. However, Finneran teaches wherein the conductive epoxy extends around the sides of the dry electrode (Fig 44; [Page 23-24]] The silver/silver chloride epoxy ink of the electrode 304 is printed over the silver epoxy circular end 311 of the trace 310 to provide a strong electrical connection between the electrode and the trace deposits). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the conductive epoxy extends around the sides of the dry electrode. Doing so covers the surface of the electrode for protection against corrosion and longevity of the electrode piece while still providing conductivity.
Regarding claim 6, Pieri teaches the surface electrode of claim 3, but fails to teach wherein the conductive epoxy is printed on the top surface of the dry electrode. However, Finneran teaches wherein the conductive epoxy is printed on the top surface of the dry electrode (Fig 44; [Page 23-24]] The silver/silver chloride epoxy ink of the electrode 304 is printed over the silver epoxy circular end 311 of the trace 310 to provide a strong electrical connection between the electrode and the trace deposits). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the conductive epoxy is printed on the top surface of the dry electrode. Doing so covers the surface of the electrode for protection and longevity of the electrode piece while still providing conductivity.
Regarding claim 8, Pieri teaches the surface electrode of claim 1, but fails to teach wherein the conductive epoxy is printed over a top surface of the dry electrode. However, Finneran teaches wherein the conductive epoxy is printed over a top surface of the dry electrode (Fig 44; [Page 23-24]] The silver/silver chloride epoxy ink of the electrode 304 is printed over the silver epoxy circular end 311 of the trace 310 to provide a strong electrical connection between the electrode and the trace deposits). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the conductive epoxy is printed over a top surface of the dry electrode. Doing so covers the surface of the electrode for protection and longevity of the electrode piece while still providing conductivity.
Regarding claim 14, Pieri teaches the multi-electrode patch of claim 13, but fails to teach wherein the conductive epoxy comprises silver epoxy. However, Finneran teaches the multi-electrode patch of claim 13, wherein the conductive epoxy comprises silver epoxy ([Page 23, line 1-5] Figure 44 is representative of a cross sectional view of the flexible electrode aπay 302. In this described exemplary embodiment each electrode 304 is silk screen printed on the substrate 306 with a highly conductive printing material such as a silver/silver chloride epoxy ink). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include the multi-electrode patch of claim 13, wherein the conductive epoxy comprises silver epoxy. Doing so creates a highly conductive epoxy for use with electrodes.
Regarding claim 16, Pieri teaches the multi-electrode patch of claim 13, but fails to teach wherein the conductive epoxy of the plurality of surface electrodes is printed on the printed dry electrodes of the plurality of surface electrodes. However, Finneran teaches wherein the conductive epoxy of the plurality of surface electrodes is printed on the printed dry electrodes of the plurality of surface electrodes (Fig 44; epoxy ink layer 310). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the conductive epoxy of the plurality of surface electrodes is printed on the printed dry electrodes of the plurality of surface electrodes. Doing so covers the surface of the electrode for protection and longevity of the electrode piece while still providing conductivity.
Regarding claim 18, Pieri teaches the multi-electrode patch of claim 13, but fails to teach wherein the conductive epoxy covers the entire top surface of the printed dry electrode and extends around the sides of the dry electrode. However, Finneran teaches wherein the conductive epoxy covers the entire top surface of the printed dry electrode and extends around the sides of the dry electrode (Fig 44; [Page 23-24]] The silver/silver chloride epoxy ink of the electrode 304 is printed over the silver epoxy circular end 311 of the trace 310 to provide a strong electrical connection between the electrode and the trace deposits). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the conductive epoxy covers the entire top surface of the printed dry electrode and extends around the sides of the dry electrode. Doing so covers the surface of the electrode for protection and longevity of the electrode piece while still providing conductivity.
Regarding claim 19, Pieri teaches the multi-electrode patch of claim 13, wherein the printed dry electrode plate of each of the plurality of surface electrodes is connected to a hub by a printed conductive track ([0032] Each electrode 1-5 is connected via a conducting track 15 to a connection hub 16), but fails to teach wherein the conductive epoxy of each of the plurality of surface electrodes includes a spillover tab configured to protect a portion of the printed conductive track proximate the dry electrode of said surface electrode. However, Finneran teaches wherein the printed dry electrode of each of the plurality of surface electrodes is connected to a hub by a printed conductive track ([Page 22, Lines 12-16] The groupings of parallel traces 288 and 290 are printed along the tails 292 and 294 and terminate at connection ends 296 and 298) (Figure 37, in other embodiments other types of electrical conductors such as electrical trace conductors or other types of conducting means may be used. As shown in Figure 37 the wires 234 terminate at electrical connectors 236 and 238) and wherein the conductive epoxy of each of the plurality of surface electrodes includes a spillover tab configured to protect a portion of the printed conductive track proximate the dry electrode of said surface electrode ([Page 23, Lines 12-16] The silver/silver chloride epoxy ink of the electrode 304 is printed over the silver epoxy circular end 311 of the trace 310 to provide a strong electrical connection between the electrode and the trace deposits) (Fig 45; conductive self-supporting adhesive 308 covers part of the trace 310). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Pieri to include wherein the conductive epoxy of each of the plurality of surface electrodes includes a spillover tab configured to protect a portion of the printed conductive track proximate the dry electrode of said surface electrode. Doing so connects the plurality of traces to a single spot for connection to an external source. Further, ensures that the traces are protected by the epoxy.
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 ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794