Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Response to Arguments
Applicant’s arguments, see page 6 to page 7, line 6, filed 02/05/2026, with respect to the rejection(s) of claim(s) 17 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burton {US 2007/0032733) 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 Therefore, the rejection has been withdrawn.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 Magill (US 2003/0212319).
Regarding Applicant’s argument that Burton is not shown to teach or suggest “treatment electrodes’ for delivering “treatment shocks to the subject” is without merit. Paragraph [0363] in Burton discloses, “Each pair of ECG electrodes preferably generates limited energy.” Granted the limited energy from these treatment shocks is relatively low, but is sufficient for stimulating the tissue between the electrode to obtain a tissue response to determine an impedance between the two electrodes.
Regarding Applicant’s argument that Burton does not show or suggest determining a confidence level for an identified treatable arrhythmia using the monitored at least one of motion or position for the subject, is without merit. Paragraph [0074] suggests means for monitoring and analyzing ECG data and paragraph [0087] discloses means for determining threshold levels associated with acquisitioned physiological data or derived analysis measures, whereby the threshold levels specify or determine normal/safe or abnormal/risk operating regions and compare currently acquisition or reviewed data or analysis for exceeding such thresholds. Paragraph [0539] discloses an ECG signal (Block 1) and an analysis algorithm process (Block 2). From the analysis (block 2) a treatable arrhythmia is identified, see paragraph [0540]. (Block 12) outputs confidence levels for the identified treatable arrhythmia, see paragraph [0550].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 17-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burton {US 2007/0032733) in view of Magill (US 2003/0212319).
Regarding claim 17, Burton meets all of the claimed features for a wearable treatment device except for a garment comprising a vest having at least one strap and at least one belt configured to be worn by the subject, see paragraph [0003].
Magill teaches using Holter monitors, and using a strap and a belt, to hold electrodes in skin contact are well known for monitoring ECG and respiratory patient signals. In addition, Magill suggests wearing a vest for monitoring ECG and respiratory signals, see paragraph [0016].
One of ordinary skill in the art would have found it obvious to combine the vest, strap and belt teachings of Magill with the Holter monitoring teaching of Burton for monitoring physical activity of a subject and providing therapy to the subject because Burton suggests using a Holter recorder device to be worn by the subject, see paragraph [0448].
Burton discloses a plurality of cardiac sensing electrodes configured to detect cardiac information for the subject, see paragraph [0045];
at least one activity sensor configured to monitor at least one of motion or position for the subject, see paragraphs [0040] to [0042];
a plurality of treatment electrodes configured to deliver treatment shocks to the subject, see paragraph [0363]; and
a controller communicably coupled to the plurality of cardiac sensing electrodes, the at least one activity sensor, and the plurality of treatment electrodes, wherein the controller is configured to guide the subject through a physical activity, see paragraphs [0044] and [0452].
Burton teaches the system may verify optimal placement of the electrodes, see paragraph [0045]. One of ordinary skill in the art would have found it obvious to measure the subject's performance of the physical activity of placing the electrodes by using the detected cardiac information for the subject and the monitored at least one of motion or position for the subject because this comprises placement of electrodes and the optimal placement is achieved when the electrodes yield optimal signal strength as measured by the system.
Burton monitors the detected cardiac information for the subject to identify whether the subject is experiencing a treatable arrhythmia, see paragraph [0074], and
determines a confidence level for an identified treatable arrhythmia using the monitored at least one of motion or position for the subject, see paragraph [0539].
Regarding claim 18, Burton discloses the controller is further configured to determine whether to deliver one or more treatment shocks via the plurality of treatment electrodes to treat the identified treatable arrhythmia using the confidence level for the identified treatable arrhythmia, see paragraph [0539].
Regarding claim 19, one of ordinary skill in the art would have found it obvious to configure the controller to determine the confidence level for the identified treatable arrhythmia using the monitored at least one of motion or position for the subject by increasing the confidence level in response to determining that the subject became motionless coinciding with the identified treatable arrhythmia because Burton teaches sleep may be used to set diagnostic threshold, see paragraphs [0389] to [0395].
Regarding claim 20, the skilled artisan would have found it obvious to configure the controller to accelerate the delivery of the one or more treatment shocks in response to the increased confidence level because a higher confidence is more likely to yield a more likely positive outcome.
Regarding claim 21, the skilled artisan would have found it obvious to configure the controller to determine the confidence level for the identified treatable arrhythmia using the monitored at least one of motion or position for the subject by decreasing the confidence level in response to determining that the subject's motion has continued after the identified treatable arrhythmia because the treatment would be more unlikely to be correcting the arrhythmia because a decreasing confidence is more likely to yield a less likely positive outcome.
Regarding claim 22, the skilled artisan would have found it obvious to configure the controller to delay the delivery of the one or more treatment shocks in response to the decreased confidence level because the delay provides additional time for the confidence level to increase for a better treatment outcome.
Regarding claim 23, one of ordinary skill in the art would have found it obvious to configure the controller with at least one subject response button to provide a responsiveness test input to the controller upon being pressed, and wherein the controller is further configured to prompt the subject to press the at least one subject response button on determining that the subject is experiencing the identified treatable arrhythmia because it is well known to provide emergency care buttons on patient monitoring system, to alert a doctor or hospital that urgent care is needed.
Regarding claim 25, the skilled artisan would have found it obvious to configure the controller to measure the subject's performance of the physical activity by measuring an ECG of the subject of the subject because the ECG electrode positioning is being performed, see paragraph [0438].
Regarding claim 26, the wearable treatment device further comprises at least one additional medical condition sensor configured to measure additional wellness information for the subject, see paragraph [0321].
Regarding claim 27, wherein the at least one additional medical condition sensor comprises at least one respiration sensor, see paragraph [0326].
Regarding claim 28, wherein the at least one additional medical condition sensor is configured to measure at least one of a respiration of the subject, see paragraph [0326].
Regarding claim 29, one of ordinary skill in the art would have found it obvious to determine how far the subject can walk in a predetermined amount of time for the physical activity because walking is a well-known exercise state activity for determining respiration, see paragraph [0089].
Regarding claim 30, one of ordinary skill in the art would have found it obvious to set the predetermined amount of time of six minutes because this amount of time limits patient cardiac output and minimizes severe health risks.
Regarding claim 31, physical activity comprises an exercise from an exercise regimen for the subject, see paragraph [0089].
Regarding claim 32, Burton discloses the exercise comprises an aerobic activity, see paragraph [0089].
Regarding claim 33, one of ordinary skill in the art would have found it obvious to configure the controller to identify a target heart rate range for the exercise; and prompt the subject to exercise with greater or lesser intensity in order to maintain the subject's heart rate in the target heart rate range because Burton suggests a decreased heart rate variability can be used to evaluate an increased risk for hypertension and cardiac damage, see paragraph [0005].
Regarding claim 34, Burton discloses the controller is configured to measure the subject's performance of the physical activity before, during, and after the physical activity, see paragraph [0192].
Regarding claim 35, Burton discloses the controller is further configured to transmit measurements of the subject's performance of the physical activity over a network, see paragraphs [0445] and [0446].
Regarding claim 36, Burton discloses the transmitted measurements of the subject's performance of the physical activity are used to perform at least one of evaluating a treatment regimen for the subject or tracking the subject's progress using the subject's performance of the physical activity see paragraphs [0044], [0045], [0445] and [0446].
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.
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/George Manuel/
Primary Examiner
Art Unit: 3792
3/6/2026