DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 39-44, 48, 50-53, 55-56, 58-60, 62, 67-69 & 71-72, specifically independent claim 39, is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 39 is directed to a method. Therefore, the claim falls within a statutory category of invention.
Step 2A, prong 1:
Claim 39 recites the method steps of:
“receiving…at least one electrical signal determined based on monitored electrical activity…from a plurality of electrodes…
“receiving…at least one motion signal based upon movement of the patient and generated by at least one motion sensor…
“recording…a wear onset event based on one or more of the at least one electrical signal and the at least one motion signal…”
“providing…a graphical representation of wear compliance of the patient based on the recorder wear onset event and the recorded wear offset event…”
“receiving…one or more notification criteria from one or more of a caregiver of the patient or a prescriber of the wearable defibrillator…”
“comparing…the patient’s wear compliance and the one or more notification criteria…”
“outputting…a notification to one or more of the patient, the caregiver of the patient or the prescriber of the wearable defibrillator if the patient’s wear compliance…
Under the broadest reasonable interpretation, claim 1 recites the method steps comprising mental processes (i.e. receiving, recording signals, providing, receiving, comparing and outputting based on event from said signals). Thus, since claim recites limitations within the mental processes the claim is directed to an abstract idea.
Step 2A, prong 2:
Claim 39, as a whole fails to integrate the abstract idea into a practical application. Claim 1 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application:
“…a wearable defibrillator…” which is directed to data gathering, see MPEP 2106.05(g).
“…by at least one processor…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…from a plurality of electrodes…” which is directed to data gathering, see MPEP 2106.05(g).
“…at least one motion sensor…” which is directed to data gathering, see MPEP 2106.05(g).
Therefore, the claim fails to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited above do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The above claims are silent to providing any treatment at all to a patient.
Step 2B
Claim 39 as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
real-time discrete data obtained from a medical device/data previously collected from a medical device (i.e. body surface/unipolar electrodes) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
producing at said computer processor a human-readable output (i.e. processor) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea”.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
The examiner also notes that the limitations of the dependent claims, i.e. claims 40-44, 48, 50, 53, 55-56, 58-60, 62, 67-69 & 71-72, define outputting by the at least one processor, transmitting by the at least one processor, detecting by the at least one processor, recording the wear onset event, notifying the indication of a patient wear compliance, etc., which further limit claim limitations already indicated above as being directed to an abstract idea. Therefore, the above dependent claims are also directed to patient-ineligible subject matter.
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 43 & 56 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.
Claim 43 recites the limitations "the acceptable impedance range" in line 11 and “the impedance level” in line 13. There is insufficient antecedent basis for these limitations in the claim.
Claim 56 recites the limitations "the impedance level" in line 3, “the impedance level” in line 5 and “the impedance threshold” in line 5. There is insufficient antecedent basis for these limitations in the claim.
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.
Claims 39-42, 48, 50, 53, 56, 58-60, 62, 67-69 & 72(s) is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gustavson et al. (US 2020/0030616).
Gustavson et al. discloses;
Claim 39
A method of providing wear compliance information as recorded by a wearable defibrillator worn by a patient, the method comprising: receiving, by at least one processor, at least one electrical signal determined based on monitored electrical activity on a skin of the patient from a plurality of electrodes operably coupled to the at least on processor;
E.G. via the disclosed WCD system 300 utilized to be assigned to a patient for wearing, wherein said WCD may further include a monitoring device having electrodes 304, 308 and a processor 330 which can monitor patient, system and environmental parameters, wherein said electrodes are attached to the patient for detecting whether the electrodes are in ‘good’ electrical contact with the patient’s body {[0036] & (Fig 3)}.
receiving, by the at least one processor, at least one motion signal based upon movement of the patient and generated by at least one motion sensor and associated circuitry operably coupled to the at least one processor;
E.G. via the disclosed WCD system including a motion sensor that generates motion event data configured to further provide a patience’s compliance {[0008], [0081] & (Fig 1)}.
recording, by the at least one processor, a wear onset event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is wearing the wearable defibrillator;
E.G. via the disclosed motion events providing an indication if the patient is and/or is not wearing the system [0081].
recording, by the at least one processor, a wear offset event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator;
E.G. via the disclosed WCD system generating compliance data 128 and viewable data 548, which is compliance data directed to if the patient is actually wearing the WCD system 101, which may be represented a percentage score {[0079]-[0080] & (Fig 5)}.
providing, by the at least one processor, a graphical representation of wear compliance of the patient based on the recorded wear onset event and the recorded wear offset event:
E.G. via the disclosed timing diagrams 1103 that depict the motion events in a statistical way based on selected times {[0128]-[0129] & (Fig 11)}.
receiving, by the at least one processor, one or more notification criteria from one or more of a caregiver of the patient or a prescriber of the wearable defibrillator;
E.G. via the disclosed diagram ‘depicting’ actions of an output device wherein an alert is outputted based on the use of a threshold {[0133] & (Fig 11)}, in which it is determined whether or not the duration of a specific period exceeds said threshold, used in order to determine the operation of said alert {[0145]-[0150] & (Fig 12)}.
comparing, by the at least one processor, the patient's wear compliance and the one or more notification criteria;
and outputting, by the at least one processor, a notification to one or more of the patient, the caregiver of the patient, or the prescriber of the wearable defibrillator if the patient's wear compliance satisfies at least one criterion of the one or more notification criteria.
E.G. via the disclosed diagram ‘depicting’ actions of an output device wherein an alert is outputted based on the use of a threshold {[0133] & (Fig 11)}, in which it is determined whether or not the duration of a specific period exceeds said threshold. The information obtained from said threshold is further used in order to determine the operation of said alert {[0145]-[0150] & (Fig 12)}.
*Note that the examiner is interpreting the disclosed inert threshold based on generated motion event data as being the claimed notification criteria ([0145]-[0150]).
Claim 40
The method of claim 39, further comprising outputting, by the at least one processor on a display operably coupled to the at least one processor, a graphical representation of the patient's wear compliance based on output information regarding the patient’s wear compliance.
E.G. via the disclosed timing diagrams {[0127] & (Fig 11)}
Claim 41
The method of claim 39, further comprising transmitting, by the at least one processor, the information regarding the patient's wear compliance to a remote server operably coupled to the at least one processor via a network interface.
E.G. via the disclosed a communication network 180 that can exchange data via a remote commlink 172 {[0066] & (Fig 1)}.
Claim 42
The method of claim 39, further comprising: detecting, by the at least one processor, an electrocardiogram (ECG) signal based on the at least one electrical signal; and controlling, by the at least one processor, the wearable defibrillator to provide a therapeutic shock to the patient in response to detection of a cardiac arrhythmia based on the detected ECG signal.
E.G. ([0040]-[0041]).
Claim 48:
The method of claim 39, wherein to record the wear onset event comprises to: detect a skin-sensor interface impedance level at one or more of the plurality of electrodes; determine whether the impedance level is within an acceptable impedance range; and if the impedance level is within the acceptable impedance range, record the wear onset event.
E.G. ([0038]-[0039]).
Claim 50:
The method of claim 39, wherein recording the wear onset event comprises: determining, by the at least one processor, whether the motion signal indicates movement of the patient and the wearable defibrillator; and if the motion signal indicates movement of the patient and the wearable defibrillator, recording, by the at least one processor, the wear onset event.
E.G. via the disclosed WCD system generating compliance data 128 and viewable data 548, based on which is compliance data directed to if the patient is actually wearing the WCD system 101, which may be represented a percentage score, wherein the patient’s compliance is based on motion event data {[0079]-[0081] & (Fig 5)}.
Claim 53:
The method of claim 39, wherein recording the wear onset event comprises: receiving, by the at least one processor, input from the patient specifying that the patient is wearing the wearable defibrillator; and recording, by the at least one processor, the wear onset event based upon the input from the patient.
E.G. via the disclosed defibrillator including a user interface worn by the user [0049].
Claim 56:
The method of claim 39, wherein recording the wear offset event comprises: detecting, by the at least one processor, a change in a skin-sensor interface impedance level at one or more of the plurality of electrodes; determining, by the at least one processor, whether the impedance level exceeds an impedance threshold; and if the impedance level exceeds the impedance threshold, recording, by the at least one processor, the wear offset event.
E.G. ([0038]-[0039]).
Claim 58:
The method of claim 39, wherein recording the wear offset event comprises: determining, by the at least one processor, that one or more of the plurality of electrodes and the at least one motion sensor and associated circuitry have been disconnected from the wearable defibrillator;
and recording, by the at least one processor, the wear offset event upon determining that one or more of the plurality of electrodes and the at least one motion sensor and associated circuitry have been disconnected.
E.G. ([0079]-[0081]).
Claim 59:
The method of claim 39, wherein recording the wear offset event comprises: detecting, by the at least one processor, that the patient has taken off the wearable defibrillator based upon analysis of the at least one motion signal;
confirming, by the at least one processor, that the at least one electrical signal indicates that the patient has taken off the wearable defibrillator;
and recording, by the at least one processor, the offset event based upon confirmation that the patient has taken off the wearable defibrillator.
E.G. via the disclosed WCD system generating compliance data 128 and viewable data 548, based on which is compliance data directed to if the patient is actually wearing the WCD system 101, which may be represented a percentage score, wherein the patient’s compliance is based on motion event data {[0079]-[0081] & (Fig 5)}.
Claim 60:
The method of claim 39, wherein recording the wear offset event comprises: receiving, by the at least one processor, input from the patient specifying that the patient is taking off the wearable defibrillator;
and recording, by the at least one processor, the wear offset event based upon the input from the patient.
E.G. ([0079]-[0081]).
Claim 62:
The method of claim 39, further comprising: determining, by the at least one processor, a current time of day; and recording, by the at least one processor, at least one of the wear onset event and the wear offset event based on one or more of the at least one motion signal, the at least one electrical signal, or the current time of day.
E.G. {[0079]-[0081], [0145]-[0150] & (Fig 12)}.
Claim 67:
The method of claim 39, wherein the notification comprises an indication of patient wear compliance relative to patient wear non-compliance.
E.G. {[0079]-[0081], [0145]-[0150] & (Fig 12)}.
Claim 68:
The method of claim 39, wherein the notification comprises an indication of recorded changes in wear compliance for the patient.
E.G. {[0079]-[0081], [0145]-[0150] & (Fig 12)}.
Claim 69:
The method of claim 39, wherein the notification comprises a timeline illustrating recorded wear onset events and wear offset events.
E.G. via the disclosed timing diagrams 1103 that depict the motion events in a statistical way based on selected times {[0128]-[0129] & (Fig 11)}.
Claim 72:
The method of claim 39, where outputting the notification of the patient's wear compliance comprises: comparing, by the at least one processor, the patient's wear compliance to one or more notification criteria;
and if the patient's wear compliance satisfies at least one criterion of the one or more notification criteria, outputting, by the at least one processor, the notification.
E.G. via the disclosed diagram ‘depicting’ actions of an output device wherein an alert is outputted based on the use of a threshold {[0133] & (Fig 11)}, in which it is determined whether or not the duration of a specific period exceeds said threshold. The information obtained from said threshold is further used in order to determine the operation of said alert {[0145]-[0150] & (Fig 12)}.
6*Note that the examiner is interpreting the disclosed inert threshold based on generated motion event data as being the claimed notification criteria ([0145]-[0150]).
Claim Objections
Claims 43-44, 55 & 71 are objected to as being dependent upon a rejected base claim, but are considered allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter: The closest art, as cited, fails to disclose, suggest and/or teach the claimed invention since the reference(s) is silent in regards to recording the wear onset by detecting one or more ECG signals, determine whether the one or more ECG signals satisfy one or more validity criteria and determine a wear onset event based on if an impedance level is within an acceptable impedance range; detecting a change in the at least one electrical signal indicating an invalid ECG and recording the wear offset event based on upon the invalid ECG signal; and obtaining a notification comprising one or more user-selectable interface control configured to provide access to recorded ECG information for one or more wear onset event, a wear offset event or a period of time when the patient was wearing the wearable defibrillator.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/ Primary Examiner, Art Unit 3796