Office Action 1: Non-Final Rejection (2024-10-24)
Rejection types: 102 - Lack of Novelty, 112 - Written Description/Enablement, Double Patenting

CLAIMS:
AMENDMENTS TO THE CLAIMS

1\. (Canceled)

2\. (New) An electronic device for long-term adhesion, the device comprising:
a physiologic data collection circuit contained within a housing;
a skin-adhering section extending from the housing, the skin-adhering section comprising a first electrode positioned on a bottom surface of the skin-adhering section, the first electrode electrically connected to the physiologic data collection circuit;
an adhesive layer positioned on the bottom surface of the skin-adhering section;
a second electrode; and
an electrical barrier configured to protect the first electrode and the second electrode from shortage.

3\. (New) The electronic device of claim 2, wherein the electrical barrier is non-conductive.

4\. (New) The electronic device of claim 2, comprising a plurality of electrical barriers.

5\. (New) The electronic device of claim 2, wherein the adhesive layer does not extend beneath the housing.

6\. (New) The electronic device of claim 2, wherein the adhesive layer comprises a hydrocolloid adhesive.

7\. (New) The electronic device of claim 2, wherein the adhesive layer extends at least partially below the housing.

8\. (New) The electronic device of claim 2, wherein the skin-adhering section comprises a flap.

9\. (New) The electronic device of claim 8, wherein the flap extends at least partially below the housing.

10\. (New) The electronic device of claim 2, wherein the physiologic data collection circuit is configured to collect cardiac rhythm data from the user.

11\. (New) The electronic device of claim 2, wherein the housing is rigid.

12\. (New) An electronic device for long-term adhesion, the device comprising:
a housing;
a physiologic data collection circuit contained in the housing;
a skin-adhering section extending from the housing;

the skin-adhering section comprising an electrode positioned on a bottom surface of the skin-adhering section, the electrode electrically connected to the physiologic data collection circuit;
the skin-adhering section comprising an adhesive layer positioned over the electrode and an adhesive strip positioned over and adhered to the adhesive layer, the adhesive strip extending outward beyond a boundary of the adhesive layer.

13\. (New) The electronic device of claim 12, wherein the adhesive strip is configured to protect the adhesive layer.

14\. (New) The electronic device of claim 12, further comprising a skin-adhering adhesive positioned on the underside of the skin-adhering section.

15\. (New) The electronic device of claim 14, wherein the skin-adhering adhesive does not extend beneath the housing.

16\. (New) The electronic device of claim 14, wherein the skin-adhering adhesive comprises a hydrocolloid adhesive.

17\. (New) The electronic device of claim 14, wherein the skin-adhering adhesive extends at least partially below the housing.

18\. (New) The electronic device of claim 12, wherein the physiologic data collection circuit is configured to collect cardiac rhythm data from the user.

19\. (New) The electronic device of claim 12, wherein the housing is rigid.

OFFICE ACTION:
DETAILED ACTION
Notice of Pre-AIA  or AIA  Status
The present application is being examined under the pre-AIA  first to invent provisions. Claims 2-19 are currently pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b)  CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA  35 U.S.C. 112, the applicant), regards as the invention.
Claims 10 and 18 recite the limitation the user in lines two (for both).  There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA  35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 2-5 and 10-11 are rejected under pre-AIA  35 U.S.C. 102b as being anticipated by Nissila 2002/0082491 (hereinafter Nissila).
Regarding claim 2, Nissila discloses an electronic device for long-term adhesion (Figures 3-7), the device comprising: a physiologic data collection circuit contained within a housing (housing 203 with circuit 202 as per [0037]); a skin-adhering section extending from the housing (127), the skin-adhering section comprising a first electrode positioned on a bottom surface of the skin-adhering section (electrode 118), the first electrode electrically connected to the physiologic data collection circuit ([0037]); an adhesive layer positioned on the bottom surface of the skin-adhering section (127); a second electrode (122); and an electrical barrier configured to protect the first electrode and the second electrode from shortage (125 as per Figures 4 and 6, see also [0032]).
Regarding claim 3, Nissila discloses that the electrical barrier is non-conductive (125 as per [0032] which details the barrier prevents electrical communication of the electrodes through it).
Regarding claim 4, Nissila discloses a plurality of electrical barriers ([0035] details that adhesive 127 in some instances can be non-conductive in nature and surround the outer edges of the band 101 just outside of the electrodes 118 and 122).
Regarding claim 5, Nissila discloses that the adhesive layer does not extend beneath the housing (127 as per Figures 4 and 6).
Regarding claim 10, Nissila discloses that the physiologic data collection circuit is configured to collect cardiac rhythm data from the user (abstract).
Regarding claim 11, Nissila discloses that the housing is rigid (housing 203 is not detailed as being specifically rigid however the Office is taking Official Notice that rigid
housings were well known before the effective filing date of the invention and for the purpose of protecting the internal sensitive electrical components, further “rigid” is a relative term).
Claims 2 and 8-9 are rejected under pre-AJA 35 U.S.C. 102(b) as being anticipated by Oakley et al. US Publication 2004/0077954 (hereinafter Oakley).
Regarding claim 2, Oakley discloses an electronic device (Figure 4) with a housing (20) holding a physiologic data collection circuit ([0008]), a skin-adhering section (extending toward 22/24 and 6/8) extend laterally from the housing (Figures 3-4) and have an electrode (at 6, 8) on a bottom surface ([0033]), the electrodes are electrically connected to the data collection circuit ([0036]), the bottom surface of the skin-adhering section has an adhesive layer to attach to the skin ([0033]), an electrical barrier (the non-conductive air gap) is between the electrodes on the bottom of the device, and is used to protect the electrodes from shorting to each other (the air gap and skin resistance prevent shorting between the electrodes).
Regarding claims 8-9, Oakley further discloses that the discs surrounding the electrodes make the distal parts the skin-adhering section, and the proximal areas of the electrode discs extend under at least part of the housing (unlabeled elements attached to electrodes 6/8 in Figure 4). Therefore, Oakley teaches that each wing includes a flap (the proximal electrode disc) that extends at least partially below the housing.
Claims 6-7 are rejected under pre-AIA  35 U.S.C. 103(a) as being
unpatentable over Nissila in view of Cross et al. US Publication 2008/0288026 (hereinafter Cross).
Regarding claim 6 , Nissila is silent on the adhesive being a hydrocolloid. Cross teaches an ECG monitoring patch that includes that the adhesive layer comprises a hydrocolloid adhesive ([0002][0048] and element 72). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the  hydrocolloid
adhesive as taught by Cross in lieu of the adhesive of Nissila in order to improve long term skin comfort.
Regarding claim 7, Nissila is silent on the adhesive extending partially beneath the housing. Cross teaches an ECG monitoring device that includes an adhesive layer extends at least partially below the housing (72 as per Figure 8). It would have been obvious to the skilled artisan before the effective filing date to utilize the adhesive placement as taught by Cross with the device of Nissila as predictable results would have ensued (depending on the application, the adhesive can be placed along any stretch of the skin-adhering section to reduce or prevent movement as desired).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA  as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-6, 8-9, and 12-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-8, and 13 of U.S. Patent No. 10,517,500. Although the claims at issue are not identical, they are not patentably distinct from each other because the same claimed components including the housing, data collection circuit, skin adhering section, adhesive layer, electrodes, electrical barrier(s), flap, and adhesive strip (where the term “over” in claim 12 would still be rejected by ‘500 as it is a relative term with no initial reference point) are claimed.
Claims 12-16, 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 10, 14, and 19 of U.S. Patent No. 10,405,799. Although the claims at issue are not identical, they are not patentably distinct from each other because the same claimed components including the housing, data collection circuit, skin adhering section, adhesive layer, electrodes, and adhesive strip (where the term “over” in claim 12 would still be rejected by ‘799 as it is a relative term with no initial reference point) are claimed. Claim 19 is rendered obvious is light of claim 3 as it details that the wings are more flexible than the housing, and given that the overall flexibility/rigidity of an object is relative, the housing is considered rigid when compared to the flexible wings/skin-adhering section.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,405,799 in view of Cross (above).  Cross teaches an adhesive layer that extends at least partially below the housing (72 as per Figure 8). It would have been obvious to the skilled artisan before the effective filing date to utilize the adhesive placement as taught by Cross with the device of ‘799 as predictable results would have ensued (depending on the application, the adhesive can be placed along any stretch of the skin-adhering section to reduce or prevent movement as desired).
Conclusion

APPLICANT REBUTTAL: D
(m ,Nr A L  Ax  C TE rTFI
Application No.:   18/806,604
JAN 24 202
Filing Date:
August 15, 2024'
REMARKS
supported by The originally filed claims, Thespecification, and the figures as filed. Accordingly, no new matter is being introduced by these amendments and die new claims. Entry of these amendments and The new claims is respectfully
requested.
In view of the tenninal disclaimer filed herewith, the foregoing amendments, the new claims, and the following remarks, Applicant respectfully submits that the application is in condition for
allowance.
Double Patentin
cg
Re
i
ect
z
ons
and
Term
m
r
al
Disclaimer
Clainis 2-6, 8-9, and 12-13 were rejected on the ground of nonstatutory obviousness-type double patenting as allegedly unpatentable over claims 1-5, 7-8, and 13 of U.S. Patent No.
10,517,500. Claims 12-16, 18-19 were rejected on the ground of nonstatutory obviousness-type double patenting as allegedly unpatentable over claims 1-3, 10, 14, and 19 of U.S. Patent No.
10,405,799. Claim 17 was rejected on the ground of nonstatutory obviousness-type double patenting as allegedly unpatentable over claim 1 of U.S. Patent No. 10,405,799 in view of Cross.
Applicant submits that the pending claims are patentably distinct from the claims of the cited patents; however, to expedite prosecution.. and without acquiescing to the rejections, Applicant is filing a terminal disclaimer herewith. For at least these reasons, Applicants respectfully requests
that the present rejections be withdrawn.
Applicant notes that "[t]he filing of a terminal disclaimer to obviate a rejection based on nonstatutory double patenting is not an admission of the propriety of the rejection. Quad Envi- ronmental Technologies Corp. v. Union Sanitary District, 946 F.2d 870, 20 USPQ2d 1392 (Fed.
function of removing the rejection of double patenting, and raises neither a presumption nor
estoppel on the merits of the rejection."' (MPEP 804.02).
Application No.: 18/806,604
Filing Date:
August 15, 2024
Rei
ections under 3
USC 112
Claims 10 and 18 were rejected under 35 U.S.C. § 112(b) as allegedly failing to particularly point out and distinctly claim the subject matter which Applicant regards as the invention. Applicant canceled Claim 10 and made a clarifying amendment to Claim 18. Thus, Applicant respectfully requests that the indefiniteness rejections of Claims 10 and 18 under
35 U.S.C. § 112(b) be withdrawn.
Repect
ions under 35
.
USC
$
102 and 35 USC
$
Claims 2-5 and 10-11 were rejected under 35 U.S.C. § 102 as being anticipated by Nissila 2002/0082491 (hereinafter Nissila). Claims 2 and 8-9 were rejected under 35 U.S.C. § 102 as being anticipated by Oakley et al. US Publication 2004/0077954 (hereinafter Oakley). Applicant
canceled Claims 2-11 and therefore respectfully asserts that the rejections are now moot.
N
ew Claims
A
re Patentable
Applicant added new claims to further clarify the distinctions between the present application and the cited references. Applicant respectfully submits that the cited references, considered either alone or in combination, do not disclose, suggest, or render obvious all the features of the new claims. For at least these reasons, Applicant respectfully submits that the new
claims are patentable over the cited references.
No Disclaimers o
r
Disavow
als
prosecution of this application. Applicant reserves the rightto pursue at a later date
sly pending or other broader or narrower claims that capture any subject matter supported by the present disclosure, including subject matter found to be specifically disclaimed herein or by any prior prosecution. Accordingly, reviewers of this or any parent, child or related prosecution history shall not reasonably infer that Applicant has made any
disclaimers or disavowals of any subject matter supported by the present application.
Application No.: 18/806,604
Filing Date:
August 15, 2024
Please charge any additional fees, including any fees for additional extension of time, or credit overpayment to Deposit Account No. 11-1410.
Respectfully submitted, KNOBBE, MARTENS, OLSON & BEAR, LLP

NEXT OFFICE ACTION: DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Claims 12-27 are currently pending. Terminal Disclaimer The terminal disclaimer filed on 01/24/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 10,405,799 and 10,517,500 has been reviewed and is accepted. The terminal disclaimer has been recorded. Reasons for Allowance The following is an examiner’s statement of reasons for allowance: The closest prior art US Patent Application 2008/0214901 to Gehman discloses an electronic device (10, Figure 2) with a housing (12) that contains a physiologic data collection circuit ([0024]). A skin adhering section (the edges of the patch; Figure 2) extend from the housing. An electrode (14) is positioned on a bottom surface of the skin adhering section (Figure 2), and each electrode is connected to the circuit (via 13). The skin adhering section having an adhesive strip (20) over a top, and extending horizontally beyond the boundary of the skin adhering section. The electrode elements (14) can be conductive adhesives for adhering to skin ( [0031]). If the adhesive electrode elements (14) are the electrodes, then Gehman fails to further disclose a first adhesive layer on the bottom surface of the skin adhering section. If the adhesive electrode elements (14) are the first adhesive layer, then the electrode (13) is not on a bottom surface of the respective wing. There is insufficient teaching, suggestion, or motivation to replace the conductive adhesive electrode with a separate conductive electrode and adhesive (both on the bottom surface of the skin adhering section). Similar designs were known in the art. Libbus (US 2010/0056881) discloses a device with a center housing (160) a skin adhering section (Figs. 1H, 1G, etc.) with electrodes (112A) and a first adhesive (116A) on the bottom surface. An adhesive strip (164 on cover 162) extends over the top of the skin adhering section. However, the adhesive strip does not extend horizontally beyond a boundary of the adhesive layer (see Figs. 11-1J), and there is insufficient teaching, suggestion, or motivation to modify the adhesive strip. Gehman teaches that the top adhesive layer is useful for securing the device to the user, but the device of Libbus is already secured with the first adhesive. Oakley (US 2004/0077954), Durand (2009/0048556) and Axelgaard (US 6,038,464) also teach many of the recited features. The adhesive strip of Durand functions as an adhesion guard and protects the first adhesive while extending horizontally beyond the first adhesive. However, the adhesive strip is not positioned over the top of the skin adhering section, and there is insufficient teaching, suggestion, or motivation to move it from the bottom surface of the device. Similarly, the adhesive strip of Axelgaard also functions as an adhesive guard and is over the first adhesive. However, this adhesive strip does not extend horizontally outward beyond the boundary of the first adhesive. Moreover, there is insufficient motivation to modify the adhesive strip of Axelgaard to extend beyond the adhesive layer because such a modification would negate the advantages of the design (particularly controlling the strength of adhesion to the skin). Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.” Conclusion

CITED REFERENCE SUMMARIES: Ref USD600351: Claims:
The ornamental design for an electrode patch, as shown and described.
Ref USD607570: Claims:
The ornamental design for an electrode patch, as shown and described.
Ref USD650911: Claims:
I claim the ornamental design for a microfluidic device, as shown and described.
Ref USD682437: Claims:
The ornamental design for a constellation of chambers for distributing pneumatic pressure, as shown and described.
Ref USD794812: Claims:
The ornamental design for a training apparatus, as shown and described.
Ref USD988518: Claims:
The ornamental design for a sensor patch, as shown and described.
Ref USD1012295: Claims:
The ornamental design for a medical electrode patch, as shown and described.
Ref US6453186: Claims:
An ECG electrode patch suitable for attachment to a neonatal or infant patient's chest comprising:
a plurality of at least three electrodes coupled to the substrate, the plurality of electrodes including at least one electrode capable of measuring the electrical activity of the right side of the patient's heart, the plurality of electrodes acquiring data for generating a standard twelve-lead ECG and three additional leads of ECG data representing the electrical activity of the right side of the patient's heart; and
a plurality of electrical conductors coupled to the plurality of electrodes and the substrate.
The ECG electrode patch of claim 1 wherein the at least one electrode capable of measuring the electrical activity of the right side of the patient's heart includes a one of (a) an electrode coupled to the substrate for attachment to the patient in approximately the fifth right intercostal space in the mid-clavicular line, (b) an electrode coupled to the substrate for attachment to the patient in approximately the fifth right intercostal space in the anterior axillary line, and (c) an electrode coupled to the substrate for attachment to the patient in approximately the fifth right intercostal space in the mid-axillary line.
The ECG electrode patch of claim 1 and further comprising a flexible backing layer coupled to the substrate.
The ECG electrode patch of claim 3 wherein the flexible backing layer is one of medical grade foam or woven cloth.
The ECG electrode patch of claim 3 wherein the flexible backing layer includes a skin-interface surface coupled to an adhesive.
The ECG electrode patch of claim 5 wherein each one of the plurality of electrodes includes a skin-interface surface coupled to a conductive gel.
The ECG electrode patch of claim 1 wherein the plurality of electrodes further includes up to six chest electrodes and up to four limb electrodes.
The ECG electrode patch of claim 1 wherein each one of the plurality of electrodes is a silver/silver chloride electrode.
The ECG electrode patch of claim 1 wherein the ECG electrode patch is labeled to identify the location of the electrodes.
The ECG electrode patch of claim 1 wherein the ECG electrode patch is labeled to identify proper placement of the patch with respect to the patient's sternum.
The ECG electrode patch of claim 1 wherein the plurality of electrical conductors are releasably connectable to an ECG machine with a single conductor.
The ECG electrode patch of claim 11 wherein the plurality of electrical conductors are releasably coupled to the single conductor with a connector, the connector including an integral latch.
The ECG electrode patch of claim 1 wherein the ECG electrode patch is a size suitable for attachment to a neonatal patient weighing less than approximately three kilograms.
The ECG electrode patch of claim 1 wherein the ECG electrode patch is a size suitable for attachment to an infant patient weighing up to approximately twenty kilograms.
The ECG electrode patch of claim 1 wherein the at least one electrode capable of measuring the electrical activity of the right side of the patient's heart is at least one electrode for attachment to the patient to the right of a patient's sagittal plane.
a flexible backing layer coupled to the substrate, the flexible backing layer including a skin-interface surface coupled to an adhesive;
a plurality of at least three electrodes coupled to the substrate, the plurality of electrodes including at least one electrode capable of measuring the electrical activity of the right side of the patient's heart, each one of the plurality of electrodes including a skin-interface surface coupled to a conductive gel, the plurality of electrodes acquiring data for generating a standard twelve-lead ECG and three additional leads of ECG data representing the electrical activity of the right side of the patient's heart;
a plurality of electrical conductors coupled to the plurality of electrodes and to the substrate; and
a releasable liner coupled to the adhesive and the conductive gel.
The ECG electrode patch of claim 16 wherein the releasable liner is a multi-tab releasable liner.
The ECG electrode patch of claim 16 wherein the at least one electrode capable of measuring the electrical activity of the right side of the patient's heart includes a one of (a) an electrode coupled to the substrate for attachment to the patient in approximately the fifth right intercostal space in the mid-clavicular line, (b) an electrode coupled to the substrate for attachment to the patient in approximately the fifth right intercostal space in the anterior axillary line, and (c) an electrode coupled to the substrate for attachment to the patient in approximately the fifth right intercostal space in the mid-axillary line.
The ECG electrode patch of claim 16 wherein the plurality of electrodes further includes up to six chest electrodes and up to four limb electrodes.
The ECG electrode patch of claim 16 wherein the flexible backing layer is one of medical grade foam or woven cloth.
The ECG electrode patch of claim 16 wherein each one of the plurality of electrodes is a silver/silver chloride electrode.
The ECG electrode patch of claim 16 wherein the ECG electrode patch is labeled to identify the location of the electrodes.
The ECG electrode patch of claim 16 wherein the ECG electrode patch is labeled to identify proper placement of the patch with respect to the patient's sternum.
The ECG electrode patch of claim 16 wherein the plurality of electrical conductors are releasably connectable to an ECG machine with a single conductor.
The ECG electrode patch of claim 24 wherein the plurality of electrical conductors are releasably coupled to the single conductor with a connector, the connector including an integral latch.
The ECG electrode patch of claim 16 wherein the ECG electrode patch is a size suitable for attachment to a neonatal patient weighing less than approximately three kilograms.
The ECG electrode patch of claim 16 wherein the ECG electrode patch is a size suitable for attachment to an infant patient weighing up to approximately twenty kilograms.
The ECG electrode patch of claim 16 wherein the at least one electrode capable of measuring the electrical activity of the right side of the patient's heart is at least one electrode for attachment to the patient to the right of a patient's sagittal plane.
A method of acquiring a neonatal or infant patient's ECG, the method comprising the acts of:
providing an ECG electrode patch including a plurality of at least three electrodes, the plurality of electrodes including at least one electrode capable of measuring the electrical activity of the right side of the patient's heart;
attaching the ECG electrode patch to the patient's chest;
acquiring data for an ECG from the plurality of electrodes; and
generating a standard twelve-lead ECG with three additional leads of ECG data representing the electrical activity of the right side of the patient's heart from the acquired data.
The method of claim 29 wherein the act of providing a plurality of electrodes including at least one electrode capable of measuring the electrical activity of the right side of the patient's heart includes providing a one of (a) an electrode for attachment to the patient in approximately the fifth right intercostal space in the mid-clavicular line, (b) an electrode for attachment to the patient in approximately the fifth right intercostal space in the anterior axillary line, and (c) an electrode for attachment to the patient in approximately the fifth right intercostal space in the mid-axillary line.
The method of claim 29 wherein the act of providing a plurality of electrodes further includes providing up to six chest electrodes and up to four limb electrodes.
The method of claim 29 wherein the act of attaching the ECG electrode patch to the patient's chest includes attaching the ECG electrode patch according to the location of the electrodes as labeled on the ECG electrode patch.
The method of claim 29 wherein the act of attaching the ECG electrode patch to the patient's chest includes attaching the ECG electrode patch according to a label on the ECG electrode patch designating the proper placement of the ECG electrode patch with respect to the patient's sternum.
The method of claim 29 and further comprising the act of detaching a releasable liner from the ECG electrode patch before the act of attaching the ECG electrode patch to the patient's chest.
The method of claim 29 and further comprising the act of releasably coupling the ECG electrode patch to an ECG machine with a single conductor.
The method of claim 29 wherein the act of attaching the ECG electrode patch to the patient's chest includes attaching the ECG electrode patch so that the at least one electrode capable of measuring the electrical activity of the right side of the patient's heart is attached to the right of a patient's sagittal plane.
a flexible circuit board including a plurality of electrical conductors coupled to a non-conductive material;
a plurality of at least three electrodes coupled to the non-conductive material and to the plurality of electrical conductors, the plurality of electrodes including at least one electrode capable of measuring the electrical activity of the right side of the patient's heart, the plurality of electrodes acquiring data for generating a standard twelve-lead ECG and three additional leads of ECG data representing the electrical activity of the right side of the patient's heart;
an adhesive coupled to a skin-interface surface of the non-conductive material;
a conductive gel coupled to a skin-interface surface of each one of the plurality of electrodes; and
The ECG electrode patch of claim 37 wherein the at least one electrode capable of measuring the electrical activity of the right side of the patient's heart includes a one of (a) an electrode for attachment to the patient in approximately the fifth right intercostal space in the mid-clavicular line, (b) an electrode for attachment to the patient in approximately the fifth right intercostal space in the anterior axillary line, and (c) an electrode for attachment to the patient in approximately the fifth right intercostal space in the mid-axillary line.
The ECG electrode patch of claim 37 and further comprising a flexible backing layer coupled to the flexible circuit board.
The ECG electrode patch of claim 39 wherein the flexible backing layer is one of medical grade foam or woven cloth.
The ECG electrode patch of claim 37 wherein the releasable liner is a multi-tab releasable liner.
The ECG electrode patch of claim 37 wherein the plurality of electrodes further includes up to six chest electrodes and up to four limb electrodes.
The ECG electrode patch of claim 37 wherein each one of the plurality of electrodes is a silver/silver chloride electrode.
The ECG electrode patch of claim 37 wherein the ECG electrode patch is labeled to identify the location of the electrodes.
The ECG electrode patch of claim 37 wherein the ECG electrode patch is labeled to identify proper placement of the patch with respect to the patient's sternum.
The ECG electrode patch of claim 37 wherein the plurality of electrical conductors are releasably connectable to an ECG machine with a single conductor.
The ECG electrode patch of claim 46 wherein the plurality of electrical conductors are releasably coupled to the single conductor with a connector, the connector including an integral latch.
The ECG electrode patch of claim 37 wherein the ECG electrode patch is a size suitable for attachment to a neonatal patient weighing less than approximately three kilograms.
The ECG electrode patch of claim 37 wherein the ECG electrode patch is a size suitable for attachment to an infant patient weighing up to approximately twenty kilograms.
The ECG electrode patch of claim 37 wherein the at least one electrode capable of measuring the electrical activity of the right side of the patient's heart is at least one electrode for attachment to the patient to the right of a patient's sagittal plane.
a plurality of at least three electrodes coupled to the substrate, the plurality of electrodes including up to six electrodes capable of measuring the electrical activity of the left side of the patient's heart, up to four limb electrodes, and up to three electrodes capable of measuring the electrical activity of the right side of the patient's heart, the plurality of electrodes acquiring data for generating a standard twelve-lead ECG and three additional leads of ECG data representing the electrical activity of the right side of the patient's heart; and
The ECG electrode patch of claim 51 wherein the up to three electrodes capable of measuring the electrical activity of the right side of the patient's heart includes a one of (a) an electrode coupled to the substrate for attachment to the patient in approximately the fifth right intercostal space in the mid-clavicular line, (b) an electrode coupled to the substrate for attachment to the patient in approximately the fifth right intercostal space in the anterior axillary line, and (c) an electrode coupled to the substrate for attachment to the patient in approximately the fifth right intercostal space in the mid-axillary line.
The ECG electrode patch of claim 51 and further comprising a flexible backing layer coupled to the substrate.
The ECG electrode patch of claim 53 wherein the flexible backing layer is one of medical grade foam or woven cloth.
The ECG electrode patch of claim 53 wherein the flexible backing layer includes a skin-interface surface coupled to an adhesive.
The ECG electrode patch of claim 55 wherein each one of the plurality of electrodes includes a skin-interface surface coupled to a conductive gel.
The ECC electrode patch of claim 56 and further comprising a releasable liner coupled to the adhesive and the conductive gel.
The ECG electrode patch of claim 57 wherein the releasable liner is a multi-tab releasable liner.
The ECG electrode patch of claim 51 wherein each one of the plurality of electrodes is a silver/silver chloride electrode.
The ECG electrode patch of claim 51 wherein the ECG electrode patch is labeled to identify the location of the electrodes.
The ECG electrode patch of claim 51 wherein the ECG electrode patch is labeled to identify proper placement of the patch with respect to the patient's sternum.
The ECG electrode patch of claim 51 wherein the plurality of electrical conductors are releasably connectable to an ECG machine with a single conductor.
The ECG electrode patch of claim 62 wherein the plurality of electrical conductors are releasably coupled to the single conductor with a connector, the connector including an integral latch.
The ECG electrode patch of claim 51 wherein the ECG electrode patch is a size suitable for attachment to a neonatal patient weighing less than approximately three kilograms.
The ECG electrode patch of claim 51 wherein the ECG electrode patch is a size suitable for attachment to an infant patient weighing up to approximately twenty kilograms.
The ECG electrode patch of claim 51 wherein:
the up to six electrodes capable of measuring the electrical activity of the left side of the patient's heart is at least one electrode for attachment to the patient to the left of a patient's sagittal plane; and
the up to three electrodes capable of measuring the electrical activity of the right side of the patient's heart is at least one electrode for attachment to the patient to the right of the patient's sagittal plane.
a plurality of at least three electrodes coupled to the substrate in a plurality of fixed positions, the plurality of electrodes including
at least one electrode capable of measuring the electrical activity from the left side of the patient's heart;
at least one limb electrode; and
at least one electrode capable of measuring the electrical activity from the right side of the patient's heart; and
The ECG electrode patch of claim wherein:
the at least one electrode capable of measuring the electrical activity from the left side of the patient's heart is at least one electrode for attachment to the patient to the left of a patient's sagittal plane; and
the at least one electrode capable of measuring the electrical activity from the right side of the patient's heart is at least one electrode for attachment to the patient to the right of the patient's sagittal plane.
The ECG electrode patch of claim 67 wherein the at least one electrode capable of measuring the electrical activity of the right side of the patient's heart includes at least one of (a) an electrode for attachment to the patient in approximately the fifth right intercostal space in the mid-clavicular line, (b) an electrode for attachment to the patient in approximately the fifth right intercostal space in the anterior axillary line, and (c) an electrode for attachment to the patient in approximately the fifth right intercostal space in the mid-axillary line.
The ECG electrode patch of claim 67 and further comprising a flexible backing layer coupled to the substrate.
The ECG electrode patch of claim 70 wherein the flexible backing layer is one of medical grade foam or woven cloth.
The ECG electrode patch of claim 70 wherein the flexible backing layer includes a skin-interface surface coupled to an adhesive.
The ECG electrode patch of claim 72 wherein each one of the plurality of electrode includes a skin-interface surface coupled to a conductive gel.
The ECG electrode patch of claim 73 and further comprising a releasable liner coupled to the adhesive and the conductive gel.
The ECG electrode patch of claim 74 wherein the releasable liner is a multi-tab releasable liner.
The ECG electrode patch of claim 67 wherein the plurality of electrodes includes six electrodes capable of measuring the electrical activity from the left side of the patient's heart, four limb electrodes, and three electrodes capable of measuring the electrical activity from the right side of the patient's heart.
The ECG electrode patch of claim 67 wherein the plurality of electrodes acquire data for generating a standard twelve-lead ECG and three additional leads of ECG data representing the electrical activity of the patient's heart from the right side of the heart.
The ECG electrode patch of claim 67 wherein each one of the plurality of electrodes is a silver/silver chloride electrode.
The ECG electrode patch of claim 67 wherein the ECG electrode patch is labeled to identify the location of the electrodes.
The ECG electrode patch of claim 67 wherein the ECG electrode patch is labeled to identify proper placement of the patch with respect to the patient's sternum.
The ECG electrode patch of claim 67 wherein the plurality of electrical conductors are releasably connectable to an ECG machine with a single conductor.
The ECG electrode patch of claim 81 wherein the plurality of electrical conductors are releasably coupled to the single conductor with a connector, the connector including an integral latch.
The ECG electrode patch of claim 67 wherein the ECG electrode patch is a size suitable for attachment to a neonatal patient weighing less than a
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