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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Foreign Priority date of 09/21/2018 acknowledged.
Response to Amendment
Examiner acknowledges all claim amendments made to claim 1 with claim 5 and 15 cancelled in prosecution. Claims 1-4, 6-14 and 16-20 remain pending in the present application.
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(s) 1-4,6-14,16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tilt et al. (US Patent No 20130281814) in view of Kwon et al. (US Patent No 20180020936) further in view of Quintanar (US Patent No 20130345539) and further in view of Roberts (US Patent No 20020133069).
Regarding claim 1, Tilt teaches an electrode patch (electrode vest… configured for electrocardiography, para [0026]), comprising: an elastic adhesive layer having an adhesive contact surface that is configured to adhere to the skin of a subject the electrode patch is applied to (adhesive layer 96… to facilitate the attachment of the electrode structure 82 to the patient’s body surface, para [0054]); an elastic conductive layer (layered structure 80 of fig. 3, para [0058]) including a plurality of measurement points (first and second electrode layers 84 and 88, para [0059]) and conductive paths the conductive paths being configured to conductively connect the plurality of measurement points to a connector; an elastic carrier layer (see carrier layer 86), and a plurality of electrodes (electrically conductive trace 102 extends from the electrode 84 through a corresponding connector strip 24, such as may connect the electrode receiving portion of layer 12 with another electrode receiving portion, para [0058]), wherein each of the plurality of electrodes is formed at least by one of the plurality of measurement points (first and second electrode layers 84 and 88, para [0059]) and a corresponding recess provided in the adhesive layer which recess extends through the entire layer thickness of the adhesive layer (see fig. 3, layer 96 and the recess through the thickness) and is provided or providable with a substance that is adhesive and conductive, such as hydrogel, so as to conductively connect the one of the plurality of measurement points to the skin of the subject (layer 90 of an electrically conductive gel, the gel layer and the electrode layers 84 and 88 form the electrode structure 82 that provides and electrically conductive interface configured to contact the body surface, para [0050]); wherein at least 90% of the area of the electrode patch is radiolucent and thereby transparent X-ray radiation by means of radiolucency of the adhesive layer and the conductive layer (the electrodes and conductive traces can be transparent under x-ray, para [0049]).
Tilt does not teach wherein the conductive layer is elastic.
However, the analogous electrode sheet and measurement interface provided by Kwon does teach wherein the conductive layer is elastic (stretchable conductive layer, para [0028]).
Therefore, it would have been obvious for one skilled in the art before the effective filing date to combine the electrode patch disclosed by Tilt to have the elastic conductive layer disclosed by Kwon in order to maintain electrical conductivity even when applied to irregular surfaces as said by Kwon (para [0036]).
The combination of Tilt and Kwon although teaching the electrode patch has X-ray radiolucent characteristics, are both quiet to the teaching of the patch thereby being transparent to electromagnetic radiation, a magnetic field, an electric field, and MRI radiation.
However, the analogous radiolucent electrode patch assembly of Quintanar does disclose an electrode patch that is transparent and radiolucent to electromagnetic radiation, a magnetic field, an electric field, and MRI radiation, [0011].
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode patch of the prior combination of Tilt and Kwon to contain radiolucent properties similar to that taught by Quintanar, as radiolucent electrodes are known in the art and electrode patches have a growing need to be radiolucent in the field as there continues to be an increased use of electromagnetic diagnostic devices and thereby needing the electrode patches to be radio-translucent as disclosed by Quintanar, [0011].
The previous combination does not explicitly teach wherein the conductive layer is arranged between the carrier layer and the adhesive layer.
However, the analogous electrode placement device for use with electrocardiograms as disclosed by Roberts does teach a conductive layer (see conductive electrode containing layer 14, [0063]) is arranged between the carrier layer (surface cover layer 16, [0063], seen as the analogous carrier layer) and the adhesive layer (adhesive coating layer 26, [0063], and further see in which the conductive layer 14 is found between the carrier layer 16 and adhesive layer 26, in fig 3 and 4).
Therefore, it would have been obvious for one skilled in the art before the effective filing date to combine the previously combined electrode patch of Tilt, Kwon and Quintanar with the stacked, enclosed conductive layer as taught by Roberts in order to protect the electrode conductive layer as well as create a more conformable electrode patch as taught by Roberts, [0063].
Regarding claim 2, the combination teaches the electrode patch according to claim 1, wherein the adhesive layer has an elastic modulus from 1.0 to 600.0 N/mm^2 (Kwon, para [0024]).
Regarding claim 3, the combination teaches the electrode patch according to claim 1, wherein the adhesive layer is at least partially optically transparent (Tilt, the electrodes and conductive traces can be transparent under x-ray, para [0049]).
Regarding claim 4, the combination teaches the electrode patch according to claim 1, wherein the conductive layer comprises a conductive particle composition (see Kwon para [0035] for variety of preferable conductive particles including a silver alloy).
Regarding claim 6, the previous combination defined by Tilt and Kwon teaches the electrode patch according to claim 1,
The combination does not teach further comprising a description layer visualizing one or more of the at least one of the pluralities of measurement points and at least one instruction and at least one reference point for supporting the predetermined positioning of the electrode patch on the subject.
However, the analogous electrode placement device for use with electrocardiograms as disclosed by Roberts teaches further comprising a description layer visualizing at least one of the pluralities of measurement points and at least one instruction and at least one reference point for supporting the predetermined positioning of the electrode patch on the subject (see indicators and instructions shown in figures 8-10 used to help guide and visualize electrode placement).
Therefore, it would have been obvious for one skilled in the art before the effective filing date to combine the previously combined electrode patch of Tilt and Kwon with the indicators and instructions disclosed by Roberts in order to allow for precise electrode lead placement on the patient (para [0028]).
Regarding claim 7, the combination teaches the electrode patch according to claim1, further comprising a dielectric layer being arranged between the adhesive layer and the conductive layer (Tilt, insulating layer 170 is formed of a dielectric material and can be applied over the electrically conductive layers, para [0067]), wherein the recess also extends through the entire layer thickness of the dielectric layer (see Tilt, fig 6, recess 110).
Regarding claim 8, the combination teaches the electrode patch according to claim1, wherein the adhesive layer is dielectric (Tilt, dielectric film over the adhesive layer, para [0052]).
Regarding claim 9, the combination teaches the electrode patch according to claim1, wherein the electrode patch is partly perforated (Roberts, leads can be surrounded by perforations, para [0077]).
Regarding claim 10, the combination teaches the electrode patch according to claim 1, wherein the electrode patch has a thickness between 10 and 1000 pm in the area of the at least one measurement point and a thickness between 10 and 1000 pm in the other areas (see Kwon, preferably have a thickness of 200 micro-meters or less, para [0016]).
Regarding claim 11, the combination teaches the electrode patch according to claim1, wherein the electrode patch comprises a hybrid adhesive layer comprising the adhesive layer, which is locally adhesively reinforced by a reinforcing adhesive layer (Tilt, the elastic conformable layer 14 can be secured relative to the insulating layer 92 by a corresponding adhesive layer, the adhesive may be applied to strategically provide the desired fixation, para [0053]).
Regarding claim 12, the combination teaches the electrode patch according to claim 1, wherein at least one of the following applies: the electrode patch has a single-piece form; and the electrode patch comprises: a first portion which is designed to extend to the right side of the subject's sternal midline in an attached state of the electrode patch, a second portion which is designed to extend to the left side of the subject's sternal midline in an attached state of the electrode patch, and a third portion which is designed to being disposed posteriorly in an attached state of the electrode patch (see Roberts fig 10 for the placements of different electrode portions of 30, 31, 32 on either side of the sternal midline and 32 being posteriorly attached).
Regarding claim 13, the combination teaches The electrode patch according to claim1, wherein the electrode patch comprises the connector, which is conductively connected to the conductive paths and is conductively connected or connectable to an internal or external device so that signals can be transferred from the conductive paths to the device via the connector; and wherein the device is at least one of magnetically and mechanically, removably connectable to the connector (Tilt, For instance, each of the electrodes 16 in the section 30 are electrically connected with corresponding pins or terminals located at the connector 40. That is, electrical traces travel from the each of the electrodes 16 along the loops 22, to corresponding base strips 44 and 46 and then electrically connect with the terminal ends in the connector 40. Each of the connectors 40 and 48 thus can be connected to an appropriate amplifying circuitry for recording and monitoring of the signals sensed by each of the respective electrodes 16, para [0039] [0040]).
Regarding claim 14, as this claim teaches a system to carry out and perform the actions of the electrode patch and no new patentable matter is being introduced within this claim, the previously stated combination of Tilt in view of Kwon further in view of Roberts would be able to carry out the same limitations of the claimed electrode patch.
Regarding claim 16, the combination teaches the electrode patch according to claim 2, wherein the adhesive layer is at least partially optically transparent (Tilt, the electrodes and conductive traces can be transparent under x-ray, para [0049]).
Regarding claim 17, the combination teaches the electrode patch according to claim 2, wherein the elastic modulus of the adhesive layer is from 2.0 to 500.0N/mm2. (See Kwon, para [0024])
Regarding claim 18, the combination teaches the electrode patch according to claim 2, wherein the elastic modulus of the adhesive layer is from 3.0 to 20.0 N/mm2. (See Kwon, para [0024])
Regarding claim 19, the combination teaches the electrode patch according to claim 4, wherein the conductive layer comprises a silver-carbon paste (see Kwon, para [0035], in which the conductive material for the paste contains a silver-carbon alloy).
Regarding claim 20, the combination teaches the electrode patch according to claim 19, wherein the silver-carbon paste has 50 to 90 wt. % silver paste with 30 to 80% solid constituents (see [0045] in which Kwon discloses the conductive paste to have a mass % of 50% or more, which encompasses the claimed range of 50 to 90 wt %, Kwon also discloses in [0055] that the solid constituents are 55-85% which overlaps the claimed range of 30 to 80%).
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered and they are partially persuasive.
In regards to the argument made about the newly amended claim 1 that the prior art of Tilt nor Kwon taught that there was an elastic carrier layer and in which the conductive layer of the electrode patch was found in between the carrier layer and the adhesive layer for the patch, has been considered but ultimately falls moot as the current prior art of record rejection does not rely on the prior art rejection from the previous office action. The examiner does agree with the applicant that the prior art of both Tilt and Kwon do not explicitly teach that the conductive layer of the electrode patch was found in between the carrier layer and the adhesive layer as currently amended, however after further search and consideration, necessitated by the amended limitation, it has been found that the other previous prior art of record of Roberts does teach a conductive layer (see conductive electrode containing layer 14, [0063]) is arranged between the carrier layer (surface cover layer 16, [0063], seen as the analogous carrier layer) and the adhesive layer (adhesive coating layer 26, [0063], and further see in which the conductive layer 14 is found between the carrier layer 16 and adhesive layer 26, in fig 3 and 4). Therefore, as the newly considered prior art of Roberts does teach the amended limitations, the claim 1 remains rejected under the new prior art of record rejection of Tilt in view of Kwon further in view of Quintanar and further in view of Roberts set forth in the present office action.
All other claims, as being dependent on the independent claim 1, also remain rejected under the current prior art of record rejection set forth.
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 KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/KYLE M. BROWN/Examiner, Art Unit 3794 /LINDA C DVORAK/ Primary Examiner, Art Unit 3794