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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 09/14/2022 has been considered by the Examiner.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/27/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 03/27/2026 with respect to claim(s) 1-15, 21-23, 26, and 27 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. New grounds of rejection detailed below.
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.
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.
Claims 1-3, 5, 7-9, 11-13, 26, and 27 are rejected under 35 U.S.C. 103 as being anticipated by Silver et al (US 20170281925) in view of Freeman et al (US 20230025409 A1), hereinafter referred to as Freeman ’23, and Freeman et al (US 20190282324 A1), hereinafter referred to as Freeman ’19.
Regarding claim 1, Silver teaches an electrode assembly (see Figs. 2A-C; configurable electrode assembly 200) comprising:
a first electrode portion (224A, see annotated Fig. 2C below); and
a second electrode portion (224B-E) disposed on the first electrode portion at an edge of the first electrode portion (see [0089], Fig. 2C; a plurality of fields 224 and a plurality of boundaries 224), the second electrode portion having a cutout, and the first electrode portion spanning the cutout (see [0092], Fig. 2C; plurality of polygons, some of which are disposed within one another). See annotated Fig. 2C below.
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Silver is silent regarding an external defibrillator comprising: an electrode storage tray; an optical sensor disposed in the electrode storage tray; and an electrode assembly disposed in the electrode storage tray, the second electrode portion comprising a visual indicator on a surface of the second electrode portion, the visual indicator configured to be detected by the optical sensor and comprising a Quick Response (QR) code, a barcode, or an alphanumeric code.
Freeman ‘23 teaches a portable medical treatment apparatus (1000) including a defibrillator system (3008) comprising:
an electrode storage tray (3018),
an optical sensor disposed in the electrode storage tray (see Freeman ‘23 [0088]; one or more sensors 3044 which may be image sensors or optical sensors determine whether a medical item has been removed; a camera may be provided in the case 3010 lid and be positioned to have a field of view of the storage area); and
an electrode assembly disposed in the electrode storage tray (see Freeman ‘23 [0033]; a plurality of electrodes 3020a-b are stored in sensor compartment 3018),
the electrode comprising a visual indicator on a surface of the electrode portion, the visual indicator configured to be detected by the optical sensor and comprising a Quick Response (QR) code, a barcode, or an alphanumeric code (see Freeman ‘23 [0088]; a QR-code or bar-code may be printed on each stored item and a camera of the lid of the case 3010 may read the codes);
a processor (3032); and
memory (3034) storing computer-executable instructions that, when executed by the processor, cause performance of operations comprising,
after the first electrode portion has been removed from the electrode storage tray:
determining, based on the optical sensor detecting the visual indicator, that the second electrode portion remains disposed in the electrode storage tray (see Freeman ‘23 [0088-0089]; the camera/sensor 3044 performs image analysis using object recognition to identify which medical items are in the case 3010 at different points in time; each removable item may have a visible code displayed thereon that identifies the medical item, and the processor 3032 may identify which visible codes are present in one or more captured images to determine which medical items are in the case and/or have been removed); and
selecting, based on a medical item having been removed from the electrode storage tray an operating mode in which the external defibrillator is to operate (see Freeman ‘23 [0092-0093]; each medical item in the case 3010 may be associated with a specific location in the query flow that uses that medical item, to which the query flow is configured to jump upon removal of the corresponding item, for example, upon the user removing electrodes 3020a-b from case 3010, the query flow may jump to a portion of the query flow related to electrotherapy).
Freeman ‘23 discloses a step in the query flow which may involve providing a selection for the user to indicate if the patient is adult or pediatric in response to entering the electrotherapy query flow (Freeman [0113]). However, Freeman is silent regarding the processor automatically performing the operation of entering a pediatric mode specifically in response to the removal of a first electrode portion.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use Silver’s multi-portion electrode with Freeman ‘23’s portable medical treatment apparatus including an operation-specific query flow procedure. One of ordinary skill in the art would have been motivated to make this modification in order to utilize Freeman’s interactive operation-specific query flow procedure so that pediatric and adult patients can be treated by the same device where the device is capable of recognizing what medical item, in this case electrode or electrode portions, have been removed for use.
Freeman ’19 teaches a system for providing feedback and instruction in the case of a cardiac event (Freeman ’19, Abstract) wherein a memory stores computer-executable instructions that, when executed by the processor, cause the treatment device to operate in a pediatric mode in response to the removed electrode as identified by a visual indicator such as a QR code (see Freeman ’19 [0302-0307]; the controller may be configured to determine what type of electrode is being used, e.g. adult, pediatric, etc., based on identifying information stored on or associated with an electrode assembly, and the controller can select/modify the instructional images based on the identified electrode type).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Freeman ‘23’s operating query flow with an automatic operating mode selection based on the removed electrodes as taught by Freeman ‘19. One of ordinary skill in the art would have been motivated to make this modification in order to reduce operator error that could result in harm to the patient from using an adult configuration for a pediatric patient.
Regarding claim 2, Silver, Freeman ’23, and Freeman ’19 teach the external defibrillator of claim 1. Silver further teaches wherein the cutout is centered within the second electrode portion (see [0092], Fig. 2C; disposed within one another; nesting is beneficial for progressively removing pre-determined areas from the example configurable electrode assembly 200). It can be appreciated that the electrode portions 224A making up the first portion, and 224B-D making up the second portion are defined by perforated boundaries 228 which define the cutout in which the first portion is currently positioned. See annotated Fig. 2C below.
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Regarding claim 3, Silver, Freeman ’23, and Freeman ’19 teach the external defibrillator of claim 1. Silver further teaches wherein the second electrode portion extends beyond the edge of the first electrode portion (see [0092], Fig. 2C; plurality of polygons, disposed within one another). See annotated Fig. 2C below.
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Regarding claim 5, Silver, Freeman ’23, and Freeman ’19 teach the external defibrillator of claim 1. Silver further teaches wherein the second electrode portion is disposed on the first electrode portion at a periphery of the first electrode portion, the periphery of the first electrode portion including the edge of the first electrode portion (see [0091], Figs. 2A-C; plurality of fields 224 includes individual fields 224A-E, each of which is separated by a boundary 228). See annotated Fig. 2C below.
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Regarding claim 7, Silver, Freeman ’23, and Freeman ’19 teach the external defibrillator of claim 1. Silver further teaches wherein the first electrode portion is removable from the second electrode portion (see [0089]; a first portion of the configurable electrode assembly 200 can be removed from the configurable electrode assembly 200 and not applied to the patient, while a second portion is applied to the patient)
Regarding claim 8, Silver, Freeman ’23, and Freeman ’19 teach the electrode assembly of claim 1. Silver further teaches wherein the first electrode portion is configured to be used without the second electrode portion to deliver therapy to a patient who is less than a threshold age (see [0089]; adjusted configuration may be preferable in the case of a smaller person, such as a child patient).
Regarding claim 9, Silver, Freeman ’23, and Freeman ’19 teach the electrode assembly of claim 1. Silver further teaches wherein the first electrode portion is removable from the second electrode portion by peeling the first electrode portion away from the second electrode portion (see [0089]; portion of the configurable electrode assembly 200 can be removed (e.g. peeled) from the configurable electrode assembly 200).
Regarding claim 11, Silver, Freeman ’23, and Freeman ’19 teach the external defibrillator of claim 1. Silver further teaches wherein: the first electrode portion comprises a first conductive area; the second electrode portion comprises a second conductive area (see [0089], Fig. 2C; plurality of fields 224); the electrode assembly further comprises a layer of gel disposed on the first conductive area and the second conductive area (see [0079]; conductive electrolyte gel); and the layer of gel is perforated (see [0091]; perforation may be formed in the electrically conductive layer).
Regarding claim 12, Silver, Freeman ’23, and Freeman ’19 teach the external defibrillator of claim 1. Silver further teaches wherein: the first electrode portion comprises a first conductive area; the second electrode portion comprises a second conductive area (see [0089], Fig. 2C; plurality of fields 224); and the first electrode portion and the second electrode portion are configured to be used together to deliver therapy to a patient who is greater than a threshold age (see [0075]; size and configure of electrode assembly according to the Broselow scale; a larger electrode may be preferable for a larger patient (e.g. adult) to provide a sufficient energy level).
Regarding claim 13, Silver, Freeman ’23, and Freeman ’19 teach the external defibrillator of claim 1. Silver further teaches wherein, the first electrode portion comprises a first conductive area; the second electrode portion comprises a second conductive area (see [0089], Fig. 2C; plurality of fields 224); an electrical cable coupled to the first electrode portion at a first end of the electrical cable (see [0088], Figs. 2A-B; lead wires 216), wherein the electrical cable is configured to be coupled to the defibrillator at a second end of the electrical cable (see [0088]; connect to a defibrillator controller); and a layer of gel disposed on the first conductive area and the second conductive area, wherein the layer of gel provides electrical conductivity between the first electrode portion and the second electrode portion (see [0079]; conductive layer 204 includes a conductive electrolyte gel).
Regarding claim 26, Silver, Freeman ’23, and Freeman ’19 teach the external defibrillator of claim 1. Silver is silent regarding wherein the optical sensor comprises a camera.
Freeman ’23 teaches wherein the optical sensor comprises a camera (see Freeman ’23 [0088]; a camera may be provided and be positioned to have a field of view of the storage area).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use Silver’s multi-portion electrode with Freeman ‘23’s portable medical treatment apparatus having an optical sensor comprising a camera to detect the removal of a medical item from the storage area. One of ordinary skill in the art would have been motivated to make this modification in order to perform image analysis of the storage area using a QR code or other visible identification code as a means of determining what medical items have been removed (Freeman ’23 [0088]).
Regarding claim 27, Silver, Freeman ’23, and Freeman ’19 teach the external defibrillator of claim 1. Silver is silent regarding wherein:
the optical sensor is a second optical sensor;
the visual indicator is a second visual indicator and the QR code is a second QR code, the barcode is a second barcode, the alphanumeric code is a second alphanumeric code;
the external defibrillator further comprises a first optical sensor disposed in the electrode storage tray; and
the first electrode portion comprises a first visual indicator on a surface of the first electrode portion,
the first visual indicator configured to be detected by the first optical sensor and comprising a first QR code, a first barcode, or a first alphanumeric code.
Freeman ‘23 teaches wherein the first electrode portion comprises a first visual indicator on a surface of the first electrode portion configured to be detected by the optical sensor and comprising a first QR code, a first barcode, or a first alphanumeric code (see Freeman ’23 [0088]; a QR-code or bar-code label may be printed on each stored item and a camera on the lid of the case 3010 may read the codes to determine what has been put into and what has been removed from the case).
Freeman ’23 is silent regarding a first and second optical sensor where the first optical sensor is configured to detect a visual indicator of the first electrode portion and the second optical sensor is configured to detect a visual indicator of the second electrode portion. Alternatively, Freeman teaches a single optical sensor that is configured to detect a visual indicator of multiple electrode portions rather than an optical sensor which can only detect one portion (Freeman ’23 [0088]).
However, in this instance, a device having the claimed optical sensors would not operate differently than the device of the prior art, because the optical sensor of the prior art is configured to detect a visual indicator of multiple medical items, e.g. a first and second electrode portion. The duplication of the optical sensor in the claimed invention has no patentable significant as there are no new and/or unexpected results produced by having a first and optical sensor as opposed to a single optical sensor. It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP 2144.04(VI), In re Harza, 274 F.2d 669.
Claim 4 is rejected under 35 U.S.C. 103 as being anticipated by Silver et al (US 20170281925) in view of Freeman et al (US 20230025409 A1), hereinafter referred to as Freeman ’23, Freeman et al (US 20190282324 A1), hereinafter referred to as Freeman ’19, and Doi et al (US 20190381308).
Regarding claim 4, Silver, Freeman ’23, and Freeman ‘19 teach the external defibrillator of claim 1. They are silent regarding wherein the edge of the first electrode portion is an outer edge of the first electrode portion, and wherein the outer edge of the first electrode portion is horizontally offset from an inner edge of the second electrode portion such that the first electrode portion overlaps part of the second electrode portion, the inner edge of the second electrode portion defining the cutout of the second electrode portion.
However, Doi teaches a low-frequency treatment device comprising an electrode assembly wherein the edge of the first electrode portion is an outer edge of the first electrode portion, and wherein the outer edge of the first electrode portion (see Doi Fig. 3; body side electrodes 4DA/4DB and body 4) is horizontally offset from an inner edge of the second electrode portion (see Doi Fig. 3; electrode pad 2 and hole 2H) such that the first electrode portion overlaps part of the second electrode portion (see Doi [0066], Fig. 3; the pad side electrode 2E is electrically connected to the body side electrode 4DA), the inner edge of the second electrode portion defining the cutout of the second electrode portion (see Doi Fig. 3; hole 2H).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the external defibrillator of Silver, Freeman ’23, and Freeman ‘19 by configuring the outer edge of the first electrode portion to be horizontally offset from an inner edge of the second electrode portion such that the first electrode portion overlaps part of the second electrode portion, and the inner edge of the second electrode portion defining the cutout of the second electrode portion as described by Doi. One of ordinary skill in the art would have been motivated to make this modification in order to detachably attach the body side (first) electrode portion from the pad (second) electrode portion (Doi [0044]).
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Silver et al (US 20170281925) in view of Freeman et al (US 20230025409 A1), hereinafter referred to as Freeman ’23, Freeman et al (US 20190282324 A1), hereinafter referred to as Freeman ’19, and Nova et al (US 6912425).
Regarding claims 6 and 10, Silver, Freeman ’23, and Freeman ’19 teach the external defibrillator of claim 1. They are silent regarding wherein the second electrode portion is coupled to the first electrode portion with an adhesive or the first electrode portion comprises a pull tab configured to be grasped by a user to peel the first electrode portion away from the second electrode portion.
Regarding claim 6, Nova teaches a medical electrode arrangement for electrotherapy applications having multiple electrode portions wherein the second electrode portion is coupled to the first electrode portion with an adhesive (see Nova [Col. 6, Lines 5 - 8], Fig. 2; attached via adhesive 230).
Regarding claim 10, Nova teaches the first electrode portion comprising a pull tab configured to be grasped by a user to peel the first electrode portion away from the second electrode portion (see Nova [Col. 6, Lines 43-45], Fig. 2; the larger electrode 205 with release liner 220 is peeled away from the smaller electrode 225). Examiner is interpreting a pull tab as being a structure that the user can grasp onto to ease the separating of electrode portions.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the external defibrillator of Silver, Freeman ’23, and Freeman ’19 by adding the adhesive attachment and pull-tab removal method of Nova. One of ordinary skill in the art would have been motivated to make this modification in order to provide options so that the electrode pad may be configured for pediatric treatment, and the larger adult electrode may be removed from the electrode arrangement with the smaller electrode being placed on the patient (Nova [Col. 2, Lines 56-60]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Silver et al (US 20170281925) in view of Freeman et al (US 20230025409 A1), hereinafter referred to as Freeman ’23, Freeman et al (US 20190282324 A1), hereinafter referred to as Freeman ’19, and Groenk (US 6115638).
Regarding claim 15, Silver, Freeman ’23, and Freeman ’19 teach the external defibrillator of claim 1. Silver further teaches wherein the first electrode portion comprises a first conductive area; the second electrode portion comprises a second conductive area (see Silver [0089], Fig. 2C; plurality of fields 224).
They are silent regarding the electrode assembly further comprising: a first layer of gel disposed on the first conductive area; a conductive film disposed on the first layer of gel; and a second layer of gel disposed on the second conductive area and the conductive film.
However, Groenk teaches an electrode configuration having a conductive release liner comprising: a first layer of gel disposed on the first conductive area (see Groenk [Col. 5, Lines 52-57], Fig. 1C; patient-engaging layer 54 of electrode 50, comprises a hydrogel material which is electrically conductive); a conductive film disposed on the first layer of gel (see Groenk [Col. 7, Lines 44-47]; electrode hydrogel which is allowed to contact the conductive sheet); and a second layer of gel disposed on the second conductive area and the conductive film (see Groenk [Col. 4, Lines 59-64], Fig. 2E; conductive sheet 72, between conductive portion 56 of an electrode pad 50 on one side of the release liner 71 with conductive portion 56 of another electrode pad 50 on an opposite side of release liner 71; [Col 3, Lines 40-45]; electrode 50 includes flexible adhesive-coated backing layer 53, and patient-engaging layer 54; patient-engaging layer 54 is preferably a hydrogel).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the external defibrillator of Silver, Freeman ’23, and Freeman ’19 by adding a first layer of gel disposed on the first conductive area; a conductive film disposed on the first layer of gel; and a second layer of gel disposed on the second conductive area and the conductive film as described by Groenk. One of ordinary skill in the art would have been motivated to make this modification in order to optimize the peel force required to remove an electrode from the release film and the electrical conductivity/resistivity between the electrodes (Groenk [Col. 2]).
Claims 14 and 21-23 are rejected under 35 U.S.C. 103 as being anticipated by Silver et al (US 20170281925) in view of Freeman et al (US 20230025409 A1), hereinafter referred to as Freeman ’23, Freeman et al (US 20190282324 A1), hereinafter referred to as Freeman ’19, and Mattila et al (US 20220117533).
Regarding claim 14, Silver, Freeman ’23, and Freeman ’19 teach the external defibrillator of claim 1. Silver further teaches wherein the first electrode portion comprises a first conductive area; the second electrode portion comprises a second conductive area (see Silver [0089], Fig. 2C; plurality of fields 224);
the electrode assembly further comprises: an electrical cable coupled to the first electrode portion at a first end of the electrical cable (see Silver [0088], Fig. 2A-B; lead wires 216), wherein the electrical cable is configured to be coupled to the defibrillator at a second end of the electrical cable (see Silver [0088]; connect to a defibrillator controller).
They are silent regarding one or more conductive tabs distributed about the inner edge of the second electrode portion and coupling the first conductive area to the second conductive area to provide electrical conductivity between the first electrode portion and the second electrode portion.
Mattila teaches one or more conductive tabs distributed about the inner edge of the second electrode portion (see Mattila Fig. 2 annotated below; circled connecting tabs 250A, 250B, and 250C) and coupling the first conductive area to the second conductive area to provide electrical conductivity between the first electrode portion and the second electrode portion (see Mattila Fig. 2, [0048]; the conductive component 270 can include a first segment 272 included in the first connector 250A).
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It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the external defibrillator of Silver, Freeman ’23, and Freeman ’19 with the conductive tabs coupling the first conductive area to the second conductive area as taught by Mattila. One of ordinary skill in the art would have been motivated to make this modification so that the patch configuration can be adjusted for different applications while ensuring an electrical connection between the first and second electrode portions when desired.
Regarding claim 21, Silver, Freeman ’23, and Freeman ’19, and Mattila teach the external defibrillator of claim 14. Silver, Freeman ’23, and Freeman ’19 are silent regarding one or more conductive tabs comprising a plurality of conductive tabs.
Mattila teaches one or more conductive tabs comprising a plurality of conductive tabs (see Mattila Fig. 2; connectors 250A, 250B, and 250C).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the external defibrillator of Silver, Freeman ’23, and Freeman ’19 with the plurality of conductive tabs as taught by Mattila. One of ordinary skill in the art would have been motivated to make this modification in order to ensure that the first and second electrode portions are coupled via conductors throughout the entire inner edge of the second electrode portion for security.
Regarding claim 22, Silver, Freeman ’23, Freeman ’19, and Mattila teach the external defibrillator of claim 21. Silver, Freeman ’23, and Freeman ’19 are silent regarding wherein the plurality of conductive tabs are evenly distributed about the inner edge of the second electrode portion.
Mattila teaches wherein the plurality of conductive tabs are evenly distributed about the inner edge of the second electrode portion (see annotated Mattila Fig. 2 above).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the external defibrillator of Silver, Freeman ’23, and Freeman ’19 with the evenly distributed plurality of conductive tabs about the inner edge of the second electrode portion as taught by Mattila. One of ordinary skill in the art would have been motivated to make this modification in order to ensure the electrical connection between the first and second electrode portions is secure throughout the entire inner edge in which the electrode portions meet.
Regarding claim 23, Silver, Freeman ’23, Freeman ’19, and Mattila teach the external defibrillator of claim 14. Silver, Freeman ’23, and Freeman ’19 are silent regarding wherein the one or more conductive tabs are made of metal, however Silver teaches an electrically conductive layer that could be made of suitable conductive materials including copper, tin, silver, silver chloride, and alloys thereof (Silver [0079]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use the established conductive metal of Silver to make the conductive tabs as taught by Mattila. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select metal as the material for the conductive tabs, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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