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 . Claims 14, 16-25, and 34-36 are currently pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14, 16-25, and 34-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 14 details in line eight, that the diagnosis is automatic, however that specific phrasing is never detailed in the original disclosure. Automated or performed by machine is disclosed but “automatically” is only ever disclosed with respect to the ECG monitoring, not the diagnosis.
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 36 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 36 recites the limitation "the particular diagnosis" in line one. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 14, 16, and 18-23, 25 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. US Publication 2020/0146930 (hereinafter Freeman) in view of Medema et al. US Publication 2018/0221645 (hereinafter Medema).
Regarding claim 14, Freeman discloses a system ([0006] and Figures 1A-3) comprising: processing circuitry (318, see also [0161]-[0162]); and memory comprising instructions that, when executed by the processing circuitry ([0256]-[0259] which details various types of memory and programs available for executing the processing steps), cause the processing circuitry to: determine that a device detected an acute health event of a patient (320 detects cardiac events and is coupled to the processor [0128][0161], where [0142] details continuous monitoring of the heart, see also [0148]-[0151]) or delivery of cardiopulmonary resuscitation (CPR) to the patient ([0165]-[0168] which details providing CPR therapy to the wearer and allows for automatic correction of compression rates); analyze sensed patient data in response to the determination ([0139]-[0140] which details monitoring for various heart events and conditions; as well as [0151][0251] which details pausing CPR to sense ECG to determine if additional therapy is needed); automatically diagnose a particular medical condition based on the analysis to generate a diagnosis ([0139]-[0141] which details monitoring for specific conditions based on the above analysis; see also [0168]-[0170] which details providing real-time instruction for compression rate utilizing the various sensors), determine a treatment based on the analysis ([0140]-[0141][0147] the determination can include shocks or compressions depending on the diagnosed condition), and provide information for guidance of a treatment of the patient to a care provider based on the analysis ([0046][0047][0150]-[0151][0168]-[0170][0251] which details providing real-time instruction to a user for compression rate utilizing the various sensors, if stimulation therapy via the electrodes has failed, CPR can then be administered as guided by the device to a second user of health care provider).
And though a health care provider would be aware some level of heart condition is taken place (the skilled artisan has no reason to provide CPR on someone not undergoing a cardiac event), Freeman does not explicitly provide that information to the user. Medema teaches a wearable cardiac defibrillator that includes alerting healthcare specifically to the diagnosis and possible additional treatment ([0069]-[0070]). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the additional processing steps as taught by Medema with the system of Freeman in order to further aid health care providers with needed information.
Regarding claim 16, Freeman discloses that the system includes an implantable medical device, a smart phone, a wearable device, a tablet, a smart TV, a smart speaker, a smart camera, or an Internet of Things device ([0006][0041][0044][0180] and Figures 1A-B which show a few versions of an output device).
Regarding claim 18, Freeman discloses that the acute health event is a cardiac event ([0036][0071][0077]).
Regarding claim 19, Freeman discloses that the information for guidance of the treatment of the patient comprises first instructions, to a user, on performing CPR or delivering medication ([0167]-[0172] which details providing CPR instructions via various outputs to a rescuer).
Regarding claim 20, Freeman discloses that the processing circuitry is further configured to: determine that the device detected delivery of CPR to the patient; analyze the delivery of the CPR to the patient; and provide second instructions indicative of a change to be made to the delivery of the CPR based on the analysis of the delivery of the CPR ([0167]-[0180] which details multiple outputs which as compression is being monitored by the sensors/processor, adjustments can be made to provide a second set of instructions by means of a rate of change difference or a depth change).
Regarding claim 21, Freeman discloses that the second instructions comprise one of: user instructions for a user to change at least one of an intensity or frequency of chest compressions of the CPR ([0167]-[0180] which details multiple outputs which as compression is being monitored by the sensors/processor, adjustments can be made to provide a second set of instructions by means of a rate of change difference or a depth change).
Regarding claim 22, Freeman discloses the system as part of analyzing the delivery of the CPR to the patient, the processing circuitry is configured to analyze at least one accelerometer signal or an electrocardiogram ([0165][0167]-[0180][0188] which details multiple outputs which as compression is being monitored by the sensors/processor, where the sensors utilized include accelerometers for depth, rate, and tilt).
Regarding claim 23, Freeman discloses that at least one of the first instructions or the second instructions comprise at least one of audio instructions or visual instructions ([0166][0169]).
Regarding claim 25, Freeman discloses that the processing circuitry is further configured to classify the ECG ([0145] details monitoring ECG signals but specifically points out arrhythmias, see also [0162] which details obtaining baseline ECG readings and using it to compare and identify event readings), wherein the information comprises the classification of the ECG ([0162] mentions identifying events based on cardiac data from ECG readings).
Regarding claim 36, Freeman discloses that the particular diagnosis comprises, sudden cardiac arrest, myocardial infarction, arrythmia, stroke, or respiratory failure ([0140]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman in view of Medema, and in further view of Nova et al. US Publication 2003/0212311 (hereinafter Nova).
Regarding claim 17, Freeman though teaches the sensors that are all capable of monitoring other acute events such as fall or respiratory failure, there is no explicit mention of those being monitored. Nova teaches a portable therapy device that can deliver CPR or other therapy for cardiac in combination with other non-cardiac events such as diabetic shock and stroke ([0028] which mentions these other non-cardiac events in combination to cardiac events). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the additional non-cardiac event monitoring as taught by Nova with the system of Freeman in order to afford a completer and more diverse device capable of monitoring multiple events and applying treatments, all of which can be monitored by the sensors already in place in Freeman.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman in view of Medema, and in further view of Gill et al. US Publication 2020/0376284 (hereinafter Gill).
Regarding claim 24, Freeman discloses that the information comprises an electrocardiogram ([0036][0129]), and wherein the processing circuitry is further configured to automatically sense the ECG in response to the detection of the acute health event in the patient ([0145][0146] which details continuous monitoring either initiated by a first or second event, or by over specific predetermined intervals). Freeman details sensing, which, as argued, is technically not recording ECG signals. Gill teaches an implantable medical device that is used for detecting arrhythmias that utilizes electrodes to sense heart signals and upon detection of an arrhythmia, automatically begins recording the heart signals ([0047]). It would have been obvious to the skilled artisan before the effective filing date to utilize the recording step as taught by Gill with the device of Freeman as predictable results would have ensued (allowing for immediate analysis of the heart’s signals).
Claims 14, 16, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Ni et al. US Publication 2007/0049976 (hereinafter Ni) in view of Patel et al. US Publication 2013/0096445 (hereinafter Patel).
Regarding claims 14 and 36, Ni discloses a system comprising: processing circuitry ([0062]); and memory ([0062]) comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to: determine that a device detected an acute health event of a patient or delivery of cardiopulmonary resuscitation (CPR) to the patient (cardiac arrhythmia is detected via electrodes at 210 of Figure 2; and also details delivers CPR 220); analyze sensed patient data in response to the determination ([0045] and Figure 3 which details that the electrodes sense heart signals and determine if an arrhythmia is taking place, then continuously checks that information after treatment), but does not go into detail regarding the diagnosis.
Patel discloses diagnosing a particular medical condition based on the analysis to generate a diagnosis ([0043]-[0045][0072] the process details that alternating sensing and treatment occurs once CPR is determined to have been stopped after a predetermined time frame, diagnosing as per [0027]); determine a treatment based on the analysis ([0035][0059][0078]-[0081]); and provide information for guidance of the treatment of the patient to a care provider based on the analysis ([0037][0077]-[0081] which details providing the analysis to a remote location/clinician), wherein the guidance of the treatment comprises the diagnosis ([0037][0039] which details transmitting the arrhythmia diagnosis to a clinician). Therefore, it would have been obvious to the skilled artisan before the effective to diagnose the cardiac event as taught by Patel instead of simply treating the cardiac event as Ni does as predictable results would have ensued (alerting the clinician to the diagnosis of the event).
Regarding claims 16 and 34, Ni discloses that the system comprises an insertable cardiac monitor (Figure 4 element 900, see also [0035]).
Regarding claim 35, Ni discloses that the insertable cardiac monitor comprises: a housing configured to be subcutaneously inserted into a patient (Figure 4 at 900), the housing comprising a cover (800/900); a plurality of electrodes (908-909 as well as 811-817, see also [0049]), at least one of the plurality of electrodes being disposed on a proximal portion of the cover and at least another one of the plurality of electrodes being disposed on a distal portion of the cover (908 and 909 which are on different portions of the cover); and sensing circuitry configured to sense at least one electrical signal indicative of the occurrence of the at least one of the acute health event of a patient ([0049]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 02/23/2026, with respect to the rejection(s) of claim(s) 14 under USC 102(A)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Freeman as modified by Medema as well as Ni modified by Patel.
Regarding claim 24, the Applicant is correct in that recording and sensing are not inherently the same thing, however the rejection remains under the same references (with the addition of Medema from claim 14) as Gill teaches that both sensing and recording takes place in the same paragraphs as previously cited.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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