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 .
Status of Claims
Claims 1-20 are currently pending and under consideration.
Specification
The disclosure is objected to because of the following informalities:
“…loads. unlike existing electrotherapy…” on page 6, paragraph [0041] should be corrected to “…loads. Unlike existing electrotherapy…”
“
“greater than 2 k Ohm” on page 22, paragraph [0112] should be corrected to “greater than 2 kOhm”
“…according to device design, In one…” on page 49, paragraph [0197] should be corrected to “…according to device design. In one…”
“In In a…” on page 56, paragraph [0216] should be corrected to “In a…”
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: The limitation of “electrically coupled the battery array via a translayer interconnect” in lines 5-6 of claim 1 is grammatically incomplete. It is recommended to change this limitation to --electrically coupled to the battery array via a translayer interconnect--. Support for this limitation is found in [0058]–[0059], [0289], and [0309]–[0310] of the USPGPub. version of the specification. Appropriate correction is required.
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.
Claims 1, 3-5, 14-18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey et. al, (US 20160346530 A1, published 12/01/2016, hereinafter known as Jeffrey) in view of Zhang et. al, (US 20220104355 A1, published 3/31/2022, hereinafter known as Zhang).
Regarding claim 1, Jeffrey discloses a wearable device, comprising:
a substrate layer (in some variations the substrate is a flexible circuit…onto which the electrode regions and other components…are placed” [0095]), the substrate layer configured to support:
an interface layer coupled to the substrate layer, wherein the interface layer is electrically coupled to the battery array via a translayer interconnect (interface 710 is connected to the electrode assembly 701 using connectors 702 as shown in Fig. 11A, [0178]), the interface layer configured to adhere the substrate layer to a body (“the electrode assemblies may be adhesive (e.g., may be adhesively held to the subject)” [0095]) and to provide electrical stimulation to the body (“neuromodulation devices described herein may incorporate some or all of the components needed for controlling and outputting the transdermal electrical stimuli” [0123]).
However, Jeffrey does not disclose a battery array comprising a plurality of battery cells, wherein at least a first battery cell is electrically coupled to a second battery cell using a conductive interconnect.
Zhang teaches electrical power storage systems [0002], which provide solutions that address and overcome technical problems associated with redundant trace fuse groups electrically connecting an electrical connection pad to a positive charge bus or negative charge bus of a printed circuit board [0006] and minimizing size of a portable battery system [0034]. A housing of a conformal wearable battery (CWB) encloses a plurality of battery cells arranged in a grid-like pattern and electrically connected to a printed circuit board (PCB) (Abstract and Fig.’s 1 and 7-9). The PCB includes an electrical connection pad that is electrically coupled to a positive terminal of a battery cell of the plurality of battery cells and a positive conductive region receiving electrical energy from one or more of the plurality of battery cells (Abstract and Fig.’s 1 and 7-9).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of a battery array of Zhang with the wearable device of Jeffrey in order to use a portable battery system with minimal size while improving overall user safety [0035].
Regarding claim 3, Jeffrey discloses wherein the substrate layer is generated by printing (“many of the structures used to form the electrode regions and connectors may be printed directly onto the base or attached to the base (e.g. by flexographic printing, silk screening, or laser printing with conductive ink)” [0127]).
Regarding claim 4, Jeffrey does not disclose wherein the first battery cell and the second battery cell are connected in series.
However, Zhang teaches the power management module includes a plurality of batteries stacked in series ( "The plurality of the battery cells may be electrically coupled together, for example, in series, in parallel, or in groups of series connected battery cells connected in parallel, etc." [0142]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the placement of the first battery cell and the second battery cell in series of Perez with the wearable device of Jeffrey in order to use a portable battery system with minimal size while improving overall user safety [0035].
Regarding claim 5, Jeffrey discloses wherein the translayer interconnect couples the interface layer and the battery array via a through-hole, wherein the through-hole comprises a perforation of the substrate layer (“electrical current from the conductive traces on the top surface may be delivered to the electrode sub-regions on the bottom surface through one or more…through holes in the nonconductive flexible substrate, as shown in the side sectional view of FIG. 19C” [0168]).
Regarding claim 14, Jeffrey discloses wherein the substrate layer comprises a polymer (“an electrode assembly such as the one shown in FIGS. 23A-23B (or FIGS. 22A-22B) may include a substrate (e.g., Kapton or other polymeric material)” [0154]).
Regarding claim 15, Jeffrey discloses wherein the polymer is polyethylene terephthalate (PET) (“flex circuit materials are well known, including, polymers such as polyester (PET)…flexible substrate (e.g. formed of a material such as polyethylene) may form the base” [0022] & [0143]).
Regarding claim 16, Jeffrey discloses wherein the interface layer comprises an electrode and an ion-conductive buffer (“electrode active regions on a first side of the assembly may include a layer of conductor (e.g., silver), over which a layer of Ag/AgCl is deposited that is sacrificial and acts as a pH buffer” [0129]).
Regarding claim 17, Jeffrey discloses wherein the ion-conductive buffer comprises a hydrogel sheet or a non-woven sponge (“a next layer of hydrogel overlays the Ag/AgCl electrode so that it can uniformly transfer charge across the active region into the skin” [0129]).
Regarding claim 18, Jeffrey discloses wherein the electrode comprises an anode and a cathode (“an anode electrode…may be positioned on the right temple area and electrically conductive when the posterior portion (e.g., the second electrode region) of the electrode assembly may be positioned so that a cathode electrode targeting the right mastoid behind the ear is positioned correctly” [0157]).
Regarding claim 19, Jeffrey discloses wherein the conductive interconnect comprises a copper track (“electrically active region of an electrode apparatus may include a nonconsumptive conducting layer…examples of the conductive nonconsumptive layers may include copper…consumptive layer may be a buffer layer disposed between the nonconsumptive layer and the hydrogel layer” [0189]) beneath a carbon conductive track (“a conductive layer such as conductive carbon” [0147]), disposed underneath a dielectric layer (“flex circuit may have a dielectric layer covering all or part of the front and/or back side, covering and insulating conductive traces” [0127]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey in view of Zhang (hereinafter known as the modified device of Jeffrey) and further in view of Roumi et. al, (US 20170309918 A1, published 10/26/2017, hereinafter known as Roumi).
Regarding claim 2, the modified device of Jeffrey discloses the wearable device as described in claim 1 above.
However, the modified device of Jeffrey does not disclose wherein the first battery cell of the battery array is staggered from the second battery cell of the battery array such that an axis of bending is present between the first battery cell and the second battery cell.
Roumi teaches three-dimensional ion transport networks and current collectors for electrodes of electrochemical cells (Abstract). The stripe layered battery may be bend or deformed in the direction normal to the plane of the separator [0066].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the axis of bending of the battery of Roumi with the modified wearable device of Jeffrey because this allows the battery to deform without substantial degradation or mechanical failure (Roumi, [0066]).
Claim 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey in view of Zhang (hereinafter known as the modified device of Jeffrey) and further in view of Martinez et. al, (US 20220061713 A1, published 03/03/2022, hereinafter known as Martinez).
Regarding claim 6, the modified device of Jeffrey discloses the wearable device as described in claim 1 above.
However, the modified device of Jeffrey does not disclose wherein the through-hole comprises a metallic ink.
Martinez teaches a wearable sensor decal may include a flexible wrapper layer, an intermediate layer, and a porous film layer…a first plurality of electrodes may be deposited on the wrapper layer (Abstract). Conductive ink for the heater electrodes may be printed in the through-holes to form the heater contacts [0045].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the use of metallic ink for the through-hole of Martinez with the modified wearable device of Jeffrey because it allows the biosensor contact to extend through the intermediate layer and the wrapper layer and the heater contact to extend through the wrapper layer (Martinez, [0045]).
Regarding claim 20, the modified device of Jeffrey discloses the wearable device as described in claim 1 above.
However, the modified device of Jeffrey does not disclose a gas channel in fluid communication with a battery cell of the battery array, the gas channel providing a vent to a space outside of the substrate layer.
Martinez teaches the intermediate layer may include a gas-permeable layer [0024].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the use of a gas-permeable layer of Martinez with the modified wearable device of Zhi because this can facilitate release of gas while containing biofluids on the sensor (Martinez, [0024]).
Claims 7 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey in view of Perez (hereinafter known as the modified device of Jeffrey) and further in view of Zhi et. al, (US 20190140315 A1, published 05/09/2019, hereinafter known as Zhi).
Regarding claim 7, the modified device of Jeffrey discloses the wearable device as described in claim 1 above.
However, the modified device of Jeffrey does not disclose wherein a battery cell of the plurality of battery cells comprises an anode and a cathode.
Zhi teaches a polyacrylamide (PAM) based flexible and rechargeable zinc-ion battery (ZIB) configuration (Abstract). A ZIB (zinc-ion battery) configuration of embodiments may comprise a manganese-dioxide (MnO.sub.2) cathode, a zinc (Zn) anode, and a PAM based polymer electrolyte [0007]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of an anode and cathode of Zhi with the modified wearable device of Jeffrey because an anode and a cathode are the key components of a battery.
Regarding claim 9, the modified device of Jeffrey discloses the wearable device as described in claim 1 above.
However, the modified device of Jeffrey does not disclose wherein the anode comprises a metal.
Zhi teaches the anode comprises a zinc (Zn) anode [0036]. It is well understood in the art that zinc is a metal.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of a metal anode of Zhi with the modified wearable device of Jeffrey because metal anodes are highly conductive.
Regarding claim 10, the modified device of Jeffrey discloses the wearable device as described in claim 1 above.
However, the modified device of Jeffrey does not disclose wherein the metal is zinc.
Zhi teaches the anode comprises a zinc (Zn) anode [0036].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the use of a zinc anode of Zhi with the modified wearable device of Jeffrey because zinc anodes protect against galvanic corrosion.
Regarding claim 11, the modified device of Jeffrey discloses the wearable device as described in claim 1 above.
However, the modified device of Jeffrey does not disclose wherein the cathode comprises a metal oxide.
Zhi teaches the cathode comprises a manganese-dioxide (MnO.sub.2) [0036]. It is well known in the art that manganese-dioxide (MnO2) is a metal oxide.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of a metal oxide cathode of Zhi with the modified wearable device of Jeffrey because metal oxide cathodes have high capacity.
Regarding claim 12, the modified device of Jeffrey discloses the wearable device as described in claim 1 above.
However, the modified device of Jeffrey does not disclose wherein the metal oxide is manganese dioxide.
Zhi teaches the cathode comprises a manganese-dioxide (MnO.sub.2) [0036].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the use of a manganese-dioxide cathode of Zhi with the modified wearable device of Jeffrey because metal dioxide cathodes have especially high capacity.
Claims 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey in view of Perez, further in view of Zhi (hereinafter known as the modified device of Jeffrey 2) and further in view of Roumi.
Regarding claim 8, the modified device of Jeffrey 2 discloses the wearable device as described in claim 7 above.
However, the modified device of Jeffrey 2 does not disclose wherein the anode and the cathode are stacked in a pair.
Roumi teaches the series of multi-layered anode and cathode electrodes may extend farther…to fit allow an electrochemical system with a predetermined number of electrode stacks/assemblies [0336].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the stacking of the anode and cathodes of Roumi with the modified wearable device of Jeffrey 2 because this results in higher energy per weight and volume (Roumi, [0330]).
Regarding claim 13, the modified device of Jeffrey 2 discloses the wearable device as described in claim 7 above.
However, the modified device of Jeffrey 2 does not disclose a separator membrane between the anode and the cathode.
Roumi teaches an electrochemical cell including anode, cathode and separator disposed between the anode and the cathode [0009].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the separator between the anode and cathode of Roumi with the modified wearable device of Jeffrey 2 because this allows ions to continue to move freely between the anode and cathode but prevents the two entities from touching, which in turn prevents potential short circuits.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Perez et. al, (US 20170021171 A1, published 11/04/2022) teaches a wearable device for suppressing appetite or hunger in a patient includes a microprocessor, electrical stimulator and at least one electrode configured to deliver electrical stimulation to the epidermis (Abstract). The power management module includes a plurality of batteries [0401].
Druke et al. (US 20210178157 A1, published 6/17/2021) teaches non-invasive nerve activation patch with electrodes connected to battery affixed to a substrate (Fig. 13).
Bergelin et al. (US 10,166,387 B2, issued 1/1/2019) teaches a wound healing patch with an array of stimulation electrodes for electrotherapy with printed battery structure (Abstract and col. 5, lines 60-64).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/F.M.K./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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