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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/03/2025 has been entered.
Response to Arguments
Applicant’s arguments filed 10/22/2025 with respect to claim(s) 1-15 and 21-25 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.
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.
Claim(s) 1-3, 5, 7-9, 11-13 is/are rejected under 35 U.S.C. 103 as being anticipated by Silver et al (US 20170281925) in view of Picardo et al (US 20020082644 A1) and Goldwasser et al (US 20170224990 A1).
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.
PNG
media_image1.png
490
761
media_image1.png
Greyscale
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.
However, Picardo teaches an external defibrillator (12) comprising:
an electrode storage tray (42);
an optical sensor (62) disposed in the electrode storage tray (see Picardo Fig. 3, [0032]; electrode storage assembly 42 includes sensor 62 which may be an optical sensor) and an electrode assembly disposed in the electrode storage tray (see Picardo Fig. 3, [0032]; electrodes 14a and 14b are stored in assembly 42).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the electrode assembly of Silver with the external defibrillator assembly as taught by Picardo. One of ordinary skill in the art would have been motivated to make this modification in order to safely store the electrode assembly with the external defibrillator in a manner which protects the electrodes from damage while ensuring the AED can be transported as a single unit for use in a medical emergency (Picardo, Abstract).
Picardo is silent regarding the second electrode portion comprising a visual indicator, wherein the visual indicator is configured to be detected by the optical sensor and comprising a QR code, a barcode, or an alphanumeric code.
However, Goldwasser teaches an apparatus for transdermal electrical stimulation wherein the electrode assembly includes an identification tag that may be a visual indicator in the form of a bar code or QR code (Goldwasser [0966]).
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 Picardo’s external defibrillator having Silver’s electrode assembly with a visual identification tag including a bar or QR code as taught by Goldwasser. One of ordinary skill in the art would have been motivated to make this modification in order to uniquely identify characteristics of the electrode assembly including the physical size and/or stimulation capacity (Goldwasser [0966]).
Regarding claim 2, Silver, Picardo, and Goldwasser 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.
PNG
media_image2.png
490
761
media_image2.png
Greyscale
Regarding claim 3, Silver, Picardo, and Goldwasser 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.
PNG
media_image3.png
490
761
media_image3.png
Greyscale
Regarding claim 5, Silver, Picardo, and Goldwasser 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.
PNG
media_image4.png
490
761
media_image4.png
Greyscale
Regarding claim 7, Silver, Picardo, and Goldwasser 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, Picardo, and Goldwasser 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, Picardo, and Goldwasser 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, Picardo, and Goldwasser 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, Picardo, and Goldwasser 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, Picardo, and Goldwasser 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).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being anticipated by Silver et al (US 20170281925) in view of Picardo et al (US 20020082644 A1), Goldwasser et al (US 20170224990 A1) and Doi et al (US 20190381308).
Regarding claim 4, Silver, Picardo, and Goldwasser 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, Picardo, and Goldwasser 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]).
Claim(s) 6 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silver et al (US 20170281925) in view of Picardo et al (US 20020082644 A1), Goldwasser et al (US 20170224990 A1) and Nova et al (US 6912425).
Regarding claims 6 and 10, Silver, Picardo, and Goldwasser 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 arrangements 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, Picardo, and Goldwasser 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(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silver et al (US 20170281925) in view of Picardo et al (US 20020082644 A1), Goldwasser et al (US 20170224990 A1), and Groenk (US 6115638).
Regarding claim 15, Silver, Picardo, and Goldwasser 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, Picardo, and Goldwasser 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]).
Claim(s) 14 and 21-23 is/are rejected under 35 U.S.C. 103 as being anticipated by Silver et al (US 20170281925) in view of Picardo et al (US 20020082644 A1), Goldwasser et al (US 20170224990 A1), and Mattila et al (US 20220117533).
Regarding claim 14, Silver, Picardo, and Goldwasser 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).
PNG
media_image5.png
450
607
media_image5.png
Greyscale
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, Picardo, and Goldwasser 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, Picardo, Goldwasser, and Mattila teach the external defibrillator of claim 14. Silver, Picardo, and Goldwasser 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, Picardo, and Goldwasser 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, Picardo, Goldwasser, and Mattila teach the external defibrillator of claim 21. Silver, Picardo, and Goldwasser 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, Picardo, and Goldwasser 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, Picardo, Goldwasser, and Mattila teach the external defibrillator of claim 14. Silver, Picardo, and Goldwasser 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.
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being anticipated by Silver et al (US 20170281925) in view of Picardo et al (US 20020082644 A1), Goldwasser et al (US 20170224990 A1), and Rogers et al (US 20170344938 A1).
Regarding claim 26, Silver, Picardo, and Goldwasser teach the external defibrillator of claim 1. They are silent regarding wherein the optical sensor comprises a camera.
Rogers teaches a system for managing the storage and identification of a plurality of tools (Rogers, Abstract) using an optical sensor comprising a camera (see [0069]; optical identification sensors including a camera).
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 optical sensor of Picardo’s external defibrillator with an optical sensor comprising a camera as taught by Rogers. One of ordinary skill in the art would have been motivated to make this modification in order to manage the storage of tools, in this case an electrode patch, and identify when a tool has been removed (Rogers [0010]).
Regarding claim 27, Silver, Picardo, and Goldwasser teach the external defibrillator of claim 1. They are 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, and 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.
However, Rogers teaches a storage system comprising multiple optical sensors (see Rogers [0090]; a first and second sensing subsystem using one or more cameras) and tools having visual indicators which may be bar codes or QR codes (Rogers 0012).
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, Picardo, and Goldwasser with multiple optical sensors and visual indicators as taught by Rogers. One of ordinary skill in the art would have been motivated to make this modification in order to manage the storage of tools, in this case an electrode patch, and identify when a tool has been removed (Rogers [0010]).
It can also be appreciated that the combination as taught by Silver, Picardo, Goldwasser, and Rogers comprises all of the structural elements claimed including an optical sensor disposed in the electrode tray and a visual indicator on the electrode. The newly recited structural elements in claim 27 of an additional optical sensor and an additional visual indicator on the surface of the first electrode portion is merely a duplication of parts found in the combination of the prior art as established in the preceding rejection of the claims. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have duplicated the claimed structures. The addition of a first/second optical sensor and visual indicator serve to perform the same function as the originally claimed structure and do not produce any new or unexpected result, therefore they do not hold any patentable significance. See MPEP 2144.04(VI)(B), In re Harza, 274 F.2d 669.
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 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792