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 .
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, the limitations recite collecting information, analyzing the information, determining compliance status and reporting the results, which constitute 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).
The above additional elements merely gather data and present the results of the analysis. The claim does not recite an improvement to ECG sensing technology, impedance measurement technology, wearable defibrillator operation, computer functionality or another technology. Rather, the additional elements are used as tools to perform the abstract idea.
Accordingly, the claim as a whole fails to integrate the judicial exception into a practical application.
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.
Response to Arguments
Applicant's arguments filed April 20, 2026 have been fully considered but they are not persuasive. The applicant argues the following points in which the examiner provides a reason as to why the arguments are not persuasive:
The applicant argues that amended claim 39 recites limitations that can not be practically performed in the human mind and therefore does not recite a mental process.
The argument is not persuasive. While claim 39 has been amended to further recited
detecting one or more ECG signals satisfy validity criteria, measuring a skin-sensor impedance level and determining whether the impedance level is outside an acceptable range, these additional limitations merely provide information used in determining patient wear compliance.
As amended, claim 39 remains directed to collecting physiological and motion information, analyzing the information to determine wear compliance and communicating the results of that analysis. The additional limitations do not recite an improvement to ECG sensing technology, impedance measurement technology, wearable defibrillator operation, computer functionality or another technology. Rather, the additional elements are used as tools to perform the recited analysis.
Accordingly, the amendments do not integrate the judicial exception into a practical application and do not render claim 39 patient eligible under 35 U.S.C § 101.
Applicant’s arguments, filed April 20, 2026, with respect to the 35 U.S.C. 112 (b), second paragraph rejections have been fully considered and are persuasive and have been withdrawn.
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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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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