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 .
Response to Amendment
The preliminary amendment filed on 29 September 2025 is hereby entered and considered.
Priority
Acknowledgment is made of Applicant's claim for priority to the following application(s):
* 17499963 filed on 13 October 2021
* 63107778 filed on 30 October 2020
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on the following date(s) is/are entered and considered by Examiner:
* 11 July 2025
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.
Claim(s) 21-40 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Claim 1 recites:
A defibrillator, comprising:
a display;
a discharge circuit configured to generate an electrical shock;
a therapy cable port configured to be coupled with defibrillation pads, to receive electrocardiogram (ECG) data of a patient from the defibrillation pads, and to output the electrical shock to the patient via the defibrillation pads; and
a processor configured to:
determine that the ECG data is indicative of ventricular fibrillation (VF);
identify a timestamp in the ECG data indicative of the VF;
generate a VF event comprising an indication of the VF and the timestamp;
identify a time that the therapy cable port outputs the electrical shock;
identify a segment of the ECG data with timestamps that occur within a period of time of the time that the therapy cable port output the electrical shock;
generate a shock event comprising an indication of the shock and the segment of the ECG data; and
cause the display to output an event record comprising the VF event and the shock event.
Step 1:
The claim as a whole falls within at least one statutory category, i.e. a process, machine, manufacture, or composition of matter.
Step 2A Prong One:
The highlighted portion, as drafted, is a process that, under its broadest reasonable interpretation, falls under “Certain methods of organizing human activity” because the steps of selecting patient data from patient records for presentation to a health care provider are traditionally performed by humans, i.e. managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). MPEP 2106.04(a)(2)(II)
The highlighted portion, as drafted, is a process that, under its broadest reasonable interpretation, falls under “Mental processes”.
But for a generic computer recited with a high level of generality in a post hoc manner to implement the abstract idea, the step of analyzing data to determine an event has been disclosed by the Specification as originally filed on 30 October 2020 in parent application 63107778 (hereafter referred to as “the Provisional Specification”) discloses that event detection may be performed manually (page 23 paragraph 0090), and the Provisional Specification further discloses that an event may be determined as a parameter being above/below a threshold (page 24 paragraph 0091 illustrating HR < 50 BPM, FiCO2 > 8).
Accordingly, these steps can be practically performed in the human mind either mentally or with pen and paper.
Accordingly, these limitations have been found to be directed towards concepts performed in the human mind (including an observation, evaluation, judgment, opinion). MPEP 2106.04(a)(2)(III)
The different categories of abstract ideas are being considered together as one single abstract idea. MPEP 2106.04(II)(B)
Dependent claim(s) recite(s) additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim(s) 23-24 reciting limitations further defining the abstract idea, which may be performed in the mind but for recitation of generic computer components, and/or may be a method of managing relationship or interactions between people).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites the following additional element(s), if any:
a display;
a discharge circuit configured to generate an electrical shock;
a therapy cable port configured to be coupled with defibrillation pads, to receive electrocardiogram (ECG) data of a patient from the defibrillation pads, and to output the electrical shock to the patient via the defibrillation pads; and
a processor configured to:
cause the display to output an event record comprising the VF event and the shock event.
The additional element(s) do(es) not integrate the abstract idea into a practical application, other than the abstract idea per se.
Regarding the defibrillator, the Provisional Specification discloses a variety of devices (page 11 paragraph 0049). The Provisional Specification further discloses any type of sensors (page 19 paragraph 0075). Similarly, the display may be interpreted as a generic display devoid of any technical details used to display data in a generic manner without specific limitations about how the data is displayed (e.g. textual display).
These limitations merely add(s) insignificant extra-solution activity to the abstract idea (mere data gathering, selecting a particular data source or type of data to be manipulated, insignificant application). MPEP 2106.05(g))
Regarding the processor, the Provisional Specification discloses a general-purpose computer) (page 14 paragraph 0062), and amount(s) to mere instructions to apply an exception (invoking computers as a tool to perform the abstract idea). MPEP 2106.05(f))
Similarly, generating data for display amounts to mere instructions to apply an exception on a generic computer because the claims merely functionally recite the display without any technical details, e.g. textual display of the pertinent data.
These limitations amount(s) to mere instructions to apply an exception (invoking computers as a tool to perform the abstract idea). MPEP 2106.05(f))
Dependent claim(s) recite(s) additional subject matter which amount to limitation(s) consistent with the additional element(s) in the independent claims.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, the additional elements do not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Accordingly, the claim recites an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use.
The additional elements, as discussed above and incorporated herein, amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use, as discussed above and incorporated herein.
Mere instructions to apply an exception, insignificant extra-solution activity, and linking to a particular technological environment using a generic computer component cannot provide an inventive concept.
Regarding the defibrillator and associated sensors, Peterson (20140272860) discloses a defibrillator with monitoring functions in a manner that would well-understood, routine, and conventional (WURC) in the pertinent arts (page 1 paragraph 0006). Regarding the display, Official Notice is taken that a generic computer display is WURC in the pertinent arts.
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
The claim is not patent eligible.
Claim(s) 24-30 recite(s) substantially similar limitations as those of claim(s) 21-23 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
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) 21-27, 30-36, 38-40 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Peterson.
Claim 21: Peterson discloses:
A defibrillator (page 2 paragraph 0036-0037 illustrating defib), comprising:
a display (Figure 10 illustrating a display);
a discharge circuit configured to generate an electrical shock (Figure 1 illustrating the discharge circuit);
a therapy cable port configured to be coupled with defibrillation pads, to receive electrocardiogram (ECG) data of a patient from the defibrillation pads, and to output the electrical shock to the patient via the defibrillation pads (page 2 paragraph 0036 illustrating ECG sensors, Figure 1 illustrating shock sensors); and
a processor (Figure 1 illustrating a processor) configured to:
determine that the ECG data is indicative of ventricular fibrillation (VF) (page 2 paragraph 0032 illustrating VF data);
identify a timestamp in the ECG data indicative of the VF (page 6-7 paragraph 0083 illustrating time stamp data);
generate a VF event comprising an indication of the VF and the timestamp (as indicated above and incorporated herein);
identify a time that the therapy cable port outputs the electrical shock (Figure 19 illustrating a shock event with time line);
identify a segment of the ECG data with timestamps that occur within a period of time of the time that the therapy cable port output the electrical shock (as indicated above and incorporated herein);
generate a shock event comprising an indication of the shock and the segment of the ECG data (Figure 19-20 illustrating recording the shock event and timeline); and
cause the display to output an event record comprising the VF event and the shock event (Figure 19-20 illustrating displaying the recorded shock data).
Claim 22: Peterson discloses:
wherein the shock event further comprises an energy level of the electrical shock (page 2 paragraph 0036 illustrating shock energy level).
Claim 23: Peterson discloses:
the period of time being a first period of time (page 8-9 paragraph 0103 illustrating a time period), the defibrillator further comprising:
a memory comprising a data buffer configured to temporarily store the segment of the ECG data for a second period of time (Figure 1 illustrating a computer memory used to store the data),
wherein the processor is further configured to generate a waveform of the segment of the ECG (page 8-9 paragraph 0103 illustrating waveforms of the associated data), and
wherein the processor is configured to generate the shock event to further comprise the waveform of the segment of the ECG (page 8-9 paragraph 0103 illustrating storing waveforms including the shock data and ECG data).
Claim(s) 24 recite(s) substantially similar limitations as those of claim(s) 21 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
Claim 25: Peterson discloses:
wherein the event comprises administration of an electrical shock (page 8-9 paragraph 0103 illustrating storing waveforms including the shock data), administration of pacing, administration of a medication, administration of cardiopulmonary resuscitation (CPR), a return of spontaneous circulation (ROSC), a cardiac arrhythmia, a physiological parameter being above an upper threshold, or the physiological parameter being below a lower threshold (these limitations are rendered optional by the limitation “or” and therefore need not be disclosed by the applied art).
Claim 26: Peterson discloses:
the physiological monitoring sensor being a first physiological monitoring sensor, the physiological monitoring data being first physiological monitoring data, wherein the processor is configured to identify the time of the event associated with the patient by analyzing the first physiological monitoring data or by analyzing second physiological monitoring data detected using a second physiological monitoring sensor (page 2 paragraph 0036 illustrating a plurality of sensors).
Claim 27: Peterson discloses:
wherein the physiological monitoring data comprises heart rate data (page 6-7 paragraph 0083 illustrating heart rate), ECG data, end tidal CO2 (EtCO2) data, respiratory rate data, fractional concentration of inspired CO2 (FiCO2) data, pulse rate data, oxygen saturation data, carbon monoxide saturation data, blood pressure data, or temperature data (these limitations are rendered optional by the limitation “or” and therefore need not be disclosed by the applied art).
Claim 30: Peterson discloses:
wherein the processor is configured to identify the segment of the physiological monitoring data with the timestamps that occur within the period of time of the time of the event associated with the patient by:
identifying a pre-event portion of the segment of the physiological monitoring data with timestamps that occur within a first period of time before the event; and
identifying a post-event portion of the segment of the physiological monitoring data with timestamps that occur within a second period of time after the event, the second period of time being longer than the first period of time (page 8-9 paragraph 0103 illustrating allowing the user to zoom in on various time periods to support diagnosis).
Claim 31: Peterson discloses:
further comprising:
a memory comprising a data buffer configured to temporarily store the pre-event portion of the segment of the physiological monitoring data for a third period of time,wherein the processor is further configured to generate a waveform of the segment of the physiological monitoring data, and
wherein the processor is configured to generate the event record to further comprise the waveform of the segment of the physiological monitoring data (Figure 1 illustrating device memory for storing data for a plurality of periods, page 8-9 paragraph 0103 illustrating waveforms of the associated data).
Claim 32: Peterson discloses:
further comprising:
an input device configured to receive an input signal from a user indicating that a first dose of a therapy has been administered to the patient (page 10 paragraph 0124 illustrating administering medication); and
a display configured to visually present a timer indicating a time that a second dose of the therapy is due to be administered to the patient (page 10 paragraph 0124 illustrating displaying a reminder for a second dose of medication),
wherein the event comprises the first dose of the therapy that has been administered to the patient (page 10 paragraph 0124 illustrating displaying a reminder for a second dose of medication).
Claim(s) 33, 34, 35, 36, 38, 39, 40 recite(s) substantially similar limitations as those of claim(s) 24, 25, 26, 27, 30, 31, 32 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
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) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson in view of O’Connor (20220072321).
Claim 28: Peterson does not disclose:
a microphone configured to detect a voice,
wherein the processor is configured to identify the time of the event associated with the patient by recognizing a keyword in the voice.
O’Connor discloses:
a microphone configured to detect a voice,
wherein the processor is configured to identify the time of the event associated with the patient by recognizing a keyword in the voice (page 30-31 paragraph 0200 illustrating a voice recognition used to augment the patient’s ECG/heart data).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to include the voice recognition of O’Connor within the defib of Peterson with the motivation of improving patient care by leveraging existing techniques of data entry, e.g. voice recognition (O’Connor; page 30-31 paragraph 0200).
Claim(s) 29, 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson in view of Quan (20190054307).
Claim 29: Peterson discloses:
wherein the physiological monitoring data comprises ECG data, (as indicated above and incorporated herein);
wherein the processor is configured to identify the time of the event associated with the patient by:
determining that the ECG data is indicative of VF (as indicated above and incorporated herein); and
Peterson does not disclose:
determining that the VF is refractory by determining that the VF persists after the patient received an electrical shock, and
wherein the processor is configured to generate the event record to further indicate the refractory VF.
Quan discloses:
determining that the VF is refractory by determining that the VF persists after the patient received an electrical shock, and
wherein the processor is configured to generate the event record to further indicate the refractory VF (page 1 paragraph 0006 illustrating recording refractory ECG readings).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to include the ECG processing of Quan within the defib of Peterson with the motivation of improving patient care by leveraging existing techniques of data processing, e.g. recognizing certain medical conditions within patient data (Quan; page 1 paragraph 0006).
Claim(s) 37 recite(s) substantially similar limitations as those of claim(s) 29 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Addison (7171269) discloses identifying CPR in EKGs (column 12 line 6-10) in a manner similar to those disclosed in the instant pending Specification as originally filed.
Packer (20130296719) discloses monitoring patient data to determine periods of CPR (page 2 paragraph 0014) in a manner similar to those disclosed in the instant pending Specification as originally filed.
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/T.N.N./
Examiner, Art Unit 3685 /KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
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