DETAILED ACTION
This action is pursuant to the claims filed on 06/11/2024. Claims 1-14 are pending. A first action on the merits of claims 1-14 is as follows.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/27/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 14 is 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.
Claim 14 recites the limitation "The portable defibrillator of claim 13, configured to connect to a smartwatch or a smartphone." However, claim 13 is directed to “The system of claim 1” in the preamble. Furthermore, it is unclear if the recitation of “a smartwatch” is intended to claim antecedent basis to prior recitations of the smartwatch in claim 1 or introduce a second smartwatch. For examination purposes, claim 14 will be interpreted to read “The system of claim 13, wherein the portable defibrillator is configured to connect to the smartwatch or a smartphone.”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4, 7, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rollie (U.S. PGPub No. 2019/0117100).
Regarding claim 1, Rollie teaches An electrocardiogram system comprising: (a) a smartwatch configured to perform an electrocardiogram of a first subject wearing the smartwatch (Fig 10-11 smartwatch 100 [0042-0045]); (b) an electrocardiogram adapter, the adapter configured to interface smartwatch sensors with an electrocardiogram lead (Fig 14A, wire 202 interfaces smartwatch 100 and associated sensors with ECG lead patch 200 as described in [0054]); and (c) an electrocardiogram lead operatively coupled to the smartwatch by the electrocardiogram adapter (ECG lead patch 200 as described in [0054]); wherein the system is configured to perform an electrocardiogram of a second subject that is not wearing the smartwatch (Fig 14A, patch 200 has four skin electrodes 204 capable of recording an ECG without wearing the watch 100).
Regarding claim 2, Rollie teaches wherein the electrocardiogram lead is configured with distal electrodes to be placed on the skin surface of the second subject (Fig 14A patch 200 has electrodes distal relative to the watch 100 and is capable of placement on a second subject).
Regarding claim 4, Rollie teaches configured for wireless transmission of data to a remote device ([0038-0039] system is configured for wireless communication with wireless system 44 including controller 42 and remote controller 46).
Regarding claim 7, Rollie teaches wherein the system is configured to register one or more electrocardiogram leads (Fig 14A, electrodes of smartwatch 100 and patch 200 are ‘registered’ as ECG leads when acquiring an ECG from said electrodes).
Regarding claim 9, Rollie teaches An electrocardiogram adapter for a smartwatch or a smartphone that is configured to connect sensors on the smartwatch or smartphone to electrocardiogram electrodes (Fig 14A, wire 202 interfaces smartwatch 100 and associated sensors with ECG lead patch 200 as described in [0054]), connections to the electrocardiogram adapter being positioned on the sides or top of the smartwatch or smartphone to provide an electrocardiogram lead connection when the smartwatch is being worn by a user or the smartphone is placed backside down on a surface or a front side is being viewed by a user (Fig 14A, interface of wire 202 to smartwatch 100 is on side of smartwatch 100).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans (U.S. PGPub No. 2015/0005608).
Regarding claim 11, Evans teaches An electrocardiogram lead comprising a reel container (Fig 4A, ECG system 100 includes reel container and ECG lead), a magnetic connector ([0044] connectors 108 are magnetic), one or more electrodes (Fig 4A, electrodes 104A-C), and a cable connecting the magnetic connector, wherein the cable is retractably wound on the reel (Fig 4A, cables 106 are retractable and housed as disclosed in [0143]).
Regarding claim 12, Evans teaches wherein the reel container is a wearable container configured to clip or attached to the clothing of a user ([0044] Fig 4A, base unit 102 can be strapped or clipped to clothing).
Claim Rejections - 35 USC § 103
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.
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rollie in view of McClung (U.S. Patent No. 11,701,048).
Regarding claim 3, Rollie teaches the device of claim 1 as stated above.
Rollie fails to teach defibrillator pads coupled to the electrocardiogram lead.
In related prior art, McClung teaches a similar electrocardiogram lead comprising defibrillator pads coupled thereto (Fig 22-22A, defib pads 40a-b integrated with electrode leads). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patch of Rollie in view of McClung to incorporate defibrillation pads to arrive at the system of claim 3. Doing so would advantageously enable the device to provide defibrillation to a patient in the event of a cardiac emergency (Col 13 lines 24-44).
Regarding claim 5, Rollie teaches the device of claim 4 as stated above.
Rollie fails to explicitly teach wherein the remote device is in a physician’s office or an emergency services terminal or device.
In related prior art, McClung teaches a similar system wherein the remote device is in a physician’s office or an emergency services terminal or device (Col 20 lines 4-18, remote device wirelessly receives data for physician review). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modfieid the remote device of Rollie in view of McClung to incorporate the remote device in a physician’s office to arrive at claim 5. Doing so would advantageously enable the ECG data to be reviewed by a professional for diagnostic purposes.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rollie in view of Evans.
Regarding claim 6, Rollie teaches the system of claim 1 as stated above.
Rollie fails to teach wherein the electrocardiogram lead is configured as a reel container having a proximal magnetic connector and one or more distal electrodes with a cable connecting the magnetic connector, wherein the cable is retractably wound on a reel of the reel container.
In related prior art, Evans teaches a similar system wherein a similar ECG lead is configured as a reel container having a proximal magnetic connector and one or more distal electrodes with a cable connecting the magnetic connector (Fig 4A, ECG system 100 with distal electrodes 104A-C, cables 106A-C, and magnetic connectors 108A-C [0044] connected to the cables 106A-C), wherein the cable is retractably wound on a reel of the reel container (Fig 4A, cables 106 are retractable and housed as disclosed in [0143]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ECG lead of Rollie in view of Evans to incorporate the ECG lead of Evans having a reel container, magnetic connector and one or more electrodes to arrive at the system of claim 6. Doing so would be a simple substitution of one well-known ECG device (Rollie, Fig 14A patch 200) for another well-known ECG device (Evans, Fig 4A ECG system 100 with reel container) to yield the predictable result of ECG electrodes capable of contacting a skin surface to collect ECG signals.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rollie in view of Albert (U.S. PGPub No. 2020/0375458).
Regarding claim 8, Rollie teaches the device of claim 4 as stated above. Rollie further teaches a software component for registration ([0039] software associated with controller and microprocessor to process ECG data includes registration of electrodes as ECG leads).
Rollie fails to explicitly teach a software component for guiding placement of electrodes in specific positions and graphic construction of a 12 lead ECG.
In related prior art, Albert teaches a similar system wherein a software component for guiding placement of electrodes in specific positions and graphic construction of a 12 lead ECG ([0108] all 12 lead electrode positions are indicated and displayed). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Rollie in view of Albert to incorporate the 12 lead ECG with software for guiding placement and graphic construction of a 12 lead ECG. Doing so would advantageously enable the system to acquire a 12 lead ECG for better diagnostic capabilities of a patient and guiding placement of said 12 leads would advantageously minimize user error in placement of the electrodes.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rollie in view of Albert-2 (U.S. PGPub No. 2021/0169392).
Regarding claim 10, Rollie teaches the device of claim 9 as stated above.
Rollie fails to teach wherein the adapter is configured as a cover that removably attaches to the smartwatch or the smartphone.
In related prior art, Albert-2 teaches a similar device wherein a similar adapter is configured as a cover that removably attaches to the smartwatch or the smartphone (Fig 16A-B, shows adapter as a cover placed on a device (smartphone in this case as shown in Figs 9-15) with electrodes thereon and connected to a retractable ECG lead 1009). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the adapter of Rollie in view of Albert-2 to incorporate the adapter as a cover that removably attaches to the smartwatch or smartphone to arrive at claim 10. Doing so would advantageously provide the smartwatch with capability to interface and connect with ECG leads to monitor the ECG of a user as disclosed by both Rollie and Albert-2.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rollie in view of Cowan (U.S. Patent No. 11,331,508).
Regarding claim 13, Rollie teaches the device of claim 1 as stated above.
Rollie fails to teach a portable defibrillator configured to operatively connect with a power bank or battery, the power bank or battery being configured to charge handheld devices.
In related prior art, Cowan teaches a portable defibrillator configured to operatively connect with a power bank or battery, the power bank or battery being configured to charge handheld devices (Fig 1-2 defibrillator 100 is portable; Col 3 Line 64 – Col 5 line 28, defibrillator 100 with power source 240 that powers modules of processor 230 associated with various devices (monitoring device 281, sensors 219)); configured to connect to a smartwatch, or a smartphone (Col 11 line 63 – Col 12 line24, disclosing defibrillator connecting to smartphone for communication purposes). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Rollie in view of Cowan to incorporate the portable defibrillator with a power bank or battery configured to charge handheld devices to arrive at claims 13-14. Doing so would advantageously enable the device to provide defibrillation to a patient in the event of a cardiac emergency and enable the battery to power various handheld devices.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794