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 § 102
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 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.
Claim(s) 1-12, 14-15, 24-25, 28-29, 31, 33-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaib et al (US 20210212397).
Regarding claim 1, Kaib discloses a non-invasive wearable ambulatory cardiac defibrillator 1300 (Fig. 13A-B, section 0112, 0224, The therapy electrodes 114 are configured to deliver one or more therapeutic defibrillating shocks to the body of the patient if it is determined that such treatment is warranted. A garment 1300 for a wearable medical device. The garment 1300 includes a front portion 1308 and a rear portion 1310 connected by side portions 1304 and adjustable straps), comprising: a garment configured to be worn around a torso of a patient (Fig. 13A-B, section 0116, a wearable cardiac monitoring/treatment device comprises a garment configured to be worn about a torso of a patient and patient monitoring circuitry disposed in the garment and configured to monitor one or more physiological signals from the patient); at least one sensing electrode 428 attached to the garment 1300 and configured to sense electrical signal(s) at the surface of the patient's skin indicative of electrical activity of the patient's heart (Fig. 13A-B, Section 0167, The sensors 428 of the sensor interface module 426 may include, for example, ECG electrodes to monitor an ECG of the patient, acoustic sensors to monitor the heart and/or lung sounds of the patient, respiration monitors to monitor the respiration of the patient, such as during a sleep study or when monitoring for sleep apnea, and/or radio-frequency based fluid monitoring sensors); two or more therapy electrodes 114 attached to the garment and configured to deliver one or more defibrillation pulses to the patient (Fig. 13A-B, section 0112, The therapy electrodes 114 are configured to deliver one or more therapeutic defibrillating shocks to the body of the patient if it is determined that such treatment is warranted), wherein the two or more therapy electrodes comprise: an anterior therapy electrode 114 configured to be disposed on an anterior portion of the patient's body (Fig. 13A, section 0224, a therapy electrode 114 and sensors 428 on the front portion 1308) ; and at least two posterior therapy electrodes 114 configured to be disposed on a posterior portion of the patient's body (Fig. 13A, section 0224, another therapy electrode 114 on the rear portion 1310); and a controller 120, 308, 310 in communication with the at least one sensing electrode and the therapy electrodes (Section 0111, the controller 120 can be mounted on a belt portion of the garment worn by the patient), the controller 120, 308, 310 configured to receive the electrical signal(s) from the at least one sensing electrodes and to cause delivery of the one or more defibrillation pulses from two or more therapy electrodes based on the controller detecting a cardiac arrhythmia in the received electrical signal(s) (Section 0111, 0139, The ECG signal acquisition circuitry also filters, amplifies, and digitizes the sensed ECG signals before sending them to the controller; Therapy control circuitry in the therapy delivery systems 308 may be configured to initiate a treatment to a patient based on one or more notifications regarding a cardiac arrhythmia detected in the patient. Therapy control circuitry in the therapy delivery systems 308 may be configured to provide at least a pacing therapy, a defibrillation therapy, and a transcutaneous electrical nerve stimulation (TENS) therapy to the patient); at least one strap 1302 attached to a back portion 1310 of the garment (Figs. 13B, 14-15, section 0224, a rear portion 1310 connected by side portions 1304 and adjustable straps 1302), the at least one strap 1302, 1406 1506 exerting a normal force on the at least two posterior therapy electrodes 114 to exert a substantially uniform normal force over the surfaces of the at least two posterior therapy electrodes 114 and/or limit displacement of the at least two posterior therapy electrodes (Figs. 13B, 14-15, section 0119, 0131, 0193, The garments as disclosed herein for such wearable medical devices are capable of providing an ergonomic fit on the patient, e.g., capable of providing optimum fit and comfort for an extended period of time and/or to avoiding stress or injury to the patient, Because of the conformability as described herein, the wearable device may also be suitable for active use, such as jogging, dancing, or sports. A conformal housing may be configured for reducing shifting of the housing when the patient is engaging in these activities, e.g., through a conforming configuration that is better able to closely fit against the patient, the shoulder portions or other portions of the garment may include an expansion mechanism configured to shorten or lengthen the straps and/or other portions of the garment).
Regarding claim 2, Kaib discloses the at least one strap is attached to an external surface of the garment (Figs. 13B, 14-15, section 0224, a rear portion 1310 connected by side portions 1304 and adjustable straps 1302).
Regarding claim 3, Kaib discloses the at least one strap comprises: a first strap 1302 extending from a right shoulder portion of the garment to a left waist portion of the garment; and a second strap 1302 extending from a left shoulder portion of the garment to a right waist portion of the garment such that the second strap crosses the first strap (Fig. 13A-B, section 0224, he garment 1300 includes a front portion 1308 and a rear portion 1310 connected by side portions 1304 and adjustable straps 1302. The garment 1300 further includes a buckle 1306 to removably secure the side portions 1304 of the garment. The garment wraps around an upper torso of the patient).
Regarding claim 4, Kaib discloses the at least one strap is adjustable in length, wherein adjustment of the length of the at least one strap adjusts the normal force exerted on the at least two posterior therapy electrodes (Figs. 13B, 14-15, section 0224, a rear portion 1310 connected by side portions 1304 and adjustable straps 1302).
Regarding claim 5, Kaib discloses the at least one strap comprises: a first strap 1302 extending from a right shoulder portion of the garment to a left shoulder portion of the garment (Fig. 13A-B); a second strap extending from the first strap to a right waist portion of the garment; and a third strap extending from the first strap to a left waist portion of the garment (Figs. 13A-B).
Regarding claim 6, Kaib discloses the first strap comprises a curved portion 1310, 1502, extending over the at least one therapy electrode 114 (Fig. 13B, 15).
Regarding claim 7, Kaib discloses the at least one strap comprises: a central strap 1310 extending at least partially over the at least one therapy electrode 114 (Fig. 13B); a first strap 1302 extending from a right shoulder portion of the garment to the central strap (Fig. 13B); a second strap 1302 extending from a left shoulder portion of the garment to the central strap 1310; a third strap1304 extending from a right waist portion of the garment to the central strap 1310 ; and a fourth strap 1304 extending from a left waist portion of the garment to the central strap 1310 (Fig. 13B).
Regarding claim 8, Kaib discloses the at least one strap 1402 is disposed internally within the garment (Fig. 14).
Regarding claim 9, Kaib discloses one of the garment 1500 and the at least one strap comprises a plurality of loops 702, wherein the other of the garment and the at least one strap comprises a hook 702 configured to engage any of the plurality of loops to adjust a tautness of the at least one strap (Fig. 15, section 0226, The garment 1500 includes a front portion 1504 to wrap around an upper torso of the subject that is secured in place by hook-and-loop fasteners).
Regarding claim 10, Kaib discloses the two or more therapy electrodes 114 are configured to deliver a biphasic shock to the patient (Section 0142, therapy delivery systems 308 can include one or more power converters for controlling the charging and discharging of the capacitor banks. In some implementations, the discharge of energy from the capacitor bank may be controlled by, for example, an H-bridge circuit as described in U.S. Pat. No. 6,280,461, titled “PATIENT-WORN ENERGY DELIVERY APPARATUS,” issued on Aug. 28, 2001 (hereinafter the “'461 patent”), and U.S. Pat. No. 8,909,335, titled “METHOD AND APPARATUS FOR APPLYING A RECTILINEAR BIPHASIC POWER WAVEFORM TO A LOAD,” issued on Dec. 9, 2014 (hereinafter the “'335 patent”), each of which is hereby incorporated herein by reference in its entirety).
Regarding claim 11, Kaib discloses the two or more therapy electrodes 114 are configured to deliver pacing pulses to the patient (Sections 0041, 0108, 0139, 0160, the therapy control circuitry is configured to initiate a treatment to the patient, the treatment comprising at least one of a pacing therapy, a defibrillation therapy, and a transcutaneous electrical nerve stimulation (TENS) therapy. the device may cause one or more therapeutic shocks (e.g., defibrillating and/or pacing shocks) to be delivered to the body of the patient. Therapy control circuitry in the therapy delivery systems 308 may be configured to provide at least a pacing therapy. The energy storage module 402 may store energy for therapeutic pulses including, for example, defibrillation pulses, pacing pulses, and/or TENS pulses).
Regarding claim 12, Kaib discloses the controller is configured to monitor for at least one of ventricular fibrillation or a ventricular tachycardia event (section 0109, A medical device as described herein can be configured to monitor a patient for a cardiac arrhythmia condition such as bradycardia, ventricular tachycardia (VT) or ventricular fibrillation (VF)).
Regarding claim 14, Kaib discloses the garment is configured to be separable from the at least one sensing electrode and the two or more therapy electrodes (section 0028, 0149, 0172, at least one treatment module removably secured to the garment to provide treatment to the patient based on the detected cardiac condition. the sensor can be disposed in a pocket or other receptacle within the garment, and can be removed. sensor can be based on devices that measure motion, volume, or tissue changes (e.g., trans-thoracic impedance techniques, rib inductance plethysmography), devices that measure airflow (e.g., thermistors for measurement of oro-nasal airflow) that can be removably secured to an attachment point (e.g., via hook and loop fasteners, snap fasteners, or pockets) on the garment ).
Regarding claim 15, Kaib discloses the controller is configured to generate ECG information from the electrical signal(s) received from the at least one sensing electrode and to cause delivery of the one or more therapeutic pulses from the at least one therapy electrode (Section 0111, 0139, The ECG signal acquisition circuitry also filters, amplifies, and digitizes the sensed ECG signals before sending them to the controller; Therapy control circuitry in the therapy delivery systems 308 may be configured to initiate a treatment to a patient based on one or more notifications regarding a cardiac arrhythmia detected in the patient. Therapy control circuitry in the therapy delivery systems 308 may be configured to provide at least a pacing therapy, a defibrillation therapy, and a transcutaneous electrical nerve stimulation (TENS) therapy to the patient).
Regarding claim 24, Kaib discloses a non-invasive wearable ambulatory cardiac defibrillator (Fig. 13A-B, section 0112, 0224, The therapy electrodes 114 are configured to deliver one or more therapeutic defibrillating shocks to the body of the patient if it is determined that such treatment is warranted. A garment 1300 for a wearable medical device. The garment 1300 includes a front portion 1308 and a rear portion 1310 connected by side portions 1304 and adjustable straps), comprising: a garment 1300 configured to be worn around a torso of a patient (Fig. 13A-B, section 0116, a wearable cardiac monitoring/treatment device comprises a garment configured to be worn about a torso of a patient and patient monitoring circuitry disposed in the garment and configured to monitor one or more physiological signals from the patient); at least one sensing electrode attached to the garment and configured to sense electrical signal(s) at the surface of the patient's skin indicative of electrical activity of the patient's heart (Fig. 13A-B, Section 0167, The sensors 428 of the sensor interface module 426 may include, for example, ECG electrodes to monitor an ECG of the patient, acoustic sensors to monitor the heart and/or lung sounds of the patient, respiration monitors to monitor the respiration of the patient, such as during a sleep study or when monitoring for sleep apnea, and/or radio-frequency based fluid monitoring sensors); two or more therapy electrodes attached to the garment and configured to deliver one or more defibrillation pulses to the patient (Fig. 13A-B, section 0112, The therapy electrodes 114 are configured to deliver one or more therapeutic defibrillating shocks to the body of the patient if it is determined that such treatment is warranted), wherein the two or more therapy electrodes comprise: an anterior therapy electrode configured to be disposed on an anterior portion of the patient's body (Fig. 13A, section 0224, a therapy electrode 114 and sensors 428 on the front portion 1308); and at least two posterior therapy electrodes configured to be disposed on a posterior portion of the patient's body (Fig. 13A, section 0224, another therapy electrode 114 on the rear portion 1310); a controller in communication with the at least one sensing electrode and the therapy electrodes, the controller configured to receive the electrical signal(s) from the at least one sensing electrodes and to cause delivery of the one or more defibrillation pulses from two or more therapy electrodes based on the controller detecting a cardiac arrhythmia in the received electrical signal(s) (Section 0111, 0139, The ECG signal acquisition circuitry also filters, amplifies, and digitizes the sensed ECG signals before sending them to the controller; Therapy control circuitry in the therapy delivery systems 308 may be configured to initiate a treatment to a patient based on one or more notifications regarding a cardiac arrhythmia detected in the patient. Therapy control circuitry in the therapy delivery systems 308 may be configured to provide at least a pacing therapy, a defibrillation therapy, and a transcutaneous electrical nerve stimulation (TENS) therapy to the patient); and a panel attached to a back portion of the garment at least partially over the at least two posterior therapy electrodes, the panel exerting a normal force on the at least two posterior therapy electrodes to exert a substantially uniform normal force over the surfaces of the at least two posterior therapy electrodes and/or limit displacement of the at least two posterior therapy electrodes, wherein the panel is made from a material that is less elastic than a material of the back portion of the garment (Figs. 13B, 14-15, section 0119, 0131, 0193, The garments as disclosed herein for such wearable medical devices are capable of providing an ergonomic fit on the patient, e.g., capable of providing optimum fit and comfort for an extended period of time and/or to avoiding stress or injury to the patient, Because of the conformability as described herein, the wearable device may also be suitable for active use, such as jogging, dancing, or sports. A conformal housing may be configured for reducing shifting of the housing when the patient is engaging in these activities, e.g., through a conforming configuration that is better able to closely fit against the patient, the shoulder portions or other portions of the garment may include an expansion mechanism configured to shorten or lengthen the straps and/or other portions of the garment).
Regarding claim 25, Kaib discloses the panel is attached to the back portion of the garment with an adhesive (Section 0138, the sensing and therapy electrodes are disposed on a single integrated disposable adhesive electrode patch and coupled to the medical device).
Regarding claim 28, Kaib discloses the panel comprises: a central section at least partially covering the at least one therapy electrode; a first strip extending from the central section to a right waist portion of the garment; and a second strip extending from the central section to a left waist portion of the garment (Fig. 13A-B, section 0224, he garment 1300 includes a front portion 1308 and a rear portion 1310 connected by side portions 1304 and adjustable straps 1302. The garment 1300 further includes a buckle 1306 to removably secure the side portions 1304 of the garment. The garment wraps around an upper torso of the patient).
Regarding claim 29, Kaib discloses the two or more therapy electrodes are configured to deliver at least one of a biphasic shock to the patient (Section 0142, therapy delivery systems 308 can include one or more power converters for controlling the charging and discharging of the capacitor banks. In some implementations, the discharge of energy from the capacitor bank may be controlled by, for example, an H-bridge circuit as described in U.S. Pat. No. 6,280,461, titled “PATIENT-WORN ENERGY DELIVERY APPARATUS,” issued on Aug. 28, 2001 (hereinafter the “'461 patent”), and U.S. Pat. No. 8,909,335, titled “METHOD AND APPARATUS FOR APPLYING A RECTILINEAR BIPHASIC POWER WAVEFORM TO A LOAD,” issued on Dec. 9, 2014 (hereinafter the “'335 patent”), each of which is hereby incorporated herein by reference in its entirety) or pacing pulses to the patient (Sections 0041, 0108, 0139, 0160, the therapy control circuitry is configured to initiate a treatment to the patient, the treatment comprising at least one of a pacing therapy, a defibrillation therapy, and a transcutaneous electrical nerve stimulation (TENS) therapy. the device may cause one or more therapeutic shocks (e.g., defibrillating and/or pacing shocks) to be delivered to the body of the patient. Therapy control circuitry in the therapy delivery systems 308 may be configured to provide at least a pacing therapy. The energy storage module 402 may store energy for therapeutic pulses including, for example, defibrillation pulses, pacing pulses, and/or TENS pulses).
Regarding claim 31, Kaib discloses the controller is configured to monitor for at least one of a ventricular fibrillation or a ventricular tachycardia event (section 0109, A medical device as described herein can be configured to monitor a patient for a cardiac arrhythmia condition such as bradycardia, ventricular tachycardia (VT) or ventricular fibrillation (VF)).
Regarding claim 33, Kaib discloses the garment is configured to be separable from the at least one sensing electrode and the two or more therapy electrodes (section 0028, 0149, 0172, at least one treatment module removably secured to the garment to provide treatment to the patient based on the detected cardiac condition. the sensor can be disposed in a pocket or other receptacle within the garment, and can be removed. sensor can be based on devices that measure motion, volume, or tissue changes (e.g., trans-thoracic impedance techniques, rib inductance plethysmography), devices that measure airflow (e.g., thermistors for measurement of oro-nasal airflow) that can be removably secured to an attachment point (e.g., via hook and loop fasteners, snap fasteners, or pockets) on the garment).
Regarding claim 34, Kaib discloses the controller is configured to generate ECG information from the electrical signal(s) received from the at least one sensing electrode and to cause delivery of the one or more therapeutic pulses from the at least one therapy electrode (Section 0111, 0139, The ECG signal acquisition circuitry also filters, amplifies, and digitizes the sensed ECG signals before sending them to the controller; Therapy control circuitry in the therapy delivery systems 308 may be configured to initiate a treatment to a patient based on one or more notifications regarding a cardiac arrhythmia detected in the patient. Therapy control circuitry in the therapy delivery systems 308 may be configured to provide at least a pacing therapy, a defibrillation therapy, and a transcutaneous electrical nerve stimulation (TENS) therapy to the patient).
Conclusion
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796