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) comprising a right shoulder portion 508 configured to engage with a right shoulder of the patient, and a left shoulder portion 508 configured to engage with a left shoulder of the patient (Fig. 5, section 0192); 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 506 of the patient's body (Figs. 5B, 13A, section 0224, another therapy electrodes on the rear portion), the anterior therapy electrode 114 (Fig. 5A) and the at least two posterior therapy electrodes 114 (Fig. 5B) comprising internally facing surfaces configured to face the patient's skin and externally facing surfaces opposite the internally facing surfaces (Fig. 15, section 0211); and a controller 120, 308, 310 in communication with the at least one sensing electrode 428 and the two or more therapy electrodes 114 (Figs. 5A-B, 15, 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 electrode and to cause delivery of the one or more defibrillation pulses from the 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 at least one tension strap 1302, configured to be attached to at least one of the right shoulder portion or the left shoulder portion of the garment 1300 (Figs. 13B, 14-15, section 0224, a rear portion 1310 connected by side portions 1304 and adjustable straps 1302), the at least one tension strap 1302 comprising at least one slider that adjusts a length of the at least one tension strap (Fig. 13B, section 0224), the at least one tension strap 1302, 1406, 1506 exerting a normal force the externally facing surfaces of 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), wherein the normal force is adjustable by adjusting the length of the at least one tension strap with the at least one slider (Fig. 13B, section 0224).
Regarding claim 2, Kaib discloses the garment further comprises an internal surface configured to face the patient’s skin and an external surface opposite the internal surface (section 0121-0122), and wherein the at least one tension strap 1302 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 tension strap comprises: a first tension strap 1302 extending from the right shoulder portion of the garment to a left waist portion of the garment; and a second tension strap 1302 extending from the left shoulder portion of the garment to a right waist portion of the garment such that the second tension strap crosses the first tension 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 5, Kaib discloses the at least one tension strap comprises: a first tension strap 1302 extending from the right shoulder portion of the garment to the left shoulder portion of the garment (Fig. 13A-B); a second tension strap extending from the first strap to the right waist portion of the garment; and a third tension strap extending from the first strap to a left waist portion of the garment (Figs. 13A-B).
Regarding claim 6, Kaib discloses the first tension strap comprises a curved portion 1310, 1502, extending over at least one of the at least two posterior therapy electrode 114 (Fig. 13B, 15).
Regarding claim 7, Kaib discloses the at least one tension strap comprises: a central tension strap 1310 extending at least partially over at least one of the at least one therapy electrode 114 (Fig. 13B); a first tension strap 1302 extending from the right shoulder portion of the garment to the central strap (Fig. 13B); a second tension strap 1302 extending from the left shoulder portion of the garment to the central strap 1310; a third tension strap 1304 extending from a right waist portion of the garment to the central strap 1310 ; and a fourth tension 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 tension 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 tension strap comprises a plurality of loops 702, wherein the other of the garment and the at least one tension 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 defibrillation pulses from the at least two or more therapy electrodes (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), the anterior therapy electrode and the at least two posterior therapy electrodes comprising internally facing surfaces configured to face the patient’s skin and externally facing surfaces opposite the internally facing surfaces (Fig. 15, section 0211); a controller in communication with the at least one sensing electrode and the two or more therapy electrodes, the controller configured to receive the electrical signal(s) from the at least one sensing electrode and to cause delivery of the one or more defibrillation pulses from the 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 stiffening panel attached to an externally facing surface of a back portion of the garment and extending at least partially over the at least two posterior therapy electrodes, the stiffening 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, wherein the stiffening 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 stiffening 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 stiffening panel comprises: a central section at least partially covering at least one of the at least two therapy electrodes 114; 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 defibrillation pulses from the two or more therapy electrodes 114 (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 36, Kaib discloses the defibrillator of claim 1, wherein the garment 1300 further comprises at least one waist portion 1304, 1504 extending at least partially around a waist of the patient configured to engage the waist (Fig. 13, 15).
Regarding claim 37, Kaib discloses wherein the right shoulder portion 508, 1302, 1402 the left shoulder portion 508, 1302, or the at least one waist portion 1304, 1504 comprises an anchor(s) 702, 1306 for attaching the at least one tension strap to the garment (Fig. 5, 13A-B, 14-15).
Regarding claim 38, Kaib discloses the defibrillator of claim 1, wherein the at least one tension strap 1302 is configured such that the normal force exerted on the externally facing surfaces of the at least two posterior therapy electrodes 114 is substantially perpendicular to a surface of a back of the patient (Fig. 13A, 15, section 0121-0122).
Response to Arguments
Applicant's arguments filed 5/19/2026 have been fully considered but they are not persuasive. Examiner finds that Kaib discloses 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) comprising a right shoulder portion 508 configured to engage with a right shoulder of the patient, and a left shoulder portion 508 configured to engage with a left shoulder of the patient (Fig. 5, section 0192); the anterior therapy electrode 114 (Fig. 5A) and the at least two posterior therapy electrodes 114 (Fig. 5B) comprising internally facing surfaces configured to face the patient's skin and externally facing surfaces opposite the internally facing surfaces (Fig. 15, section 0211).
Conclusion
THIS ACTION IS MADE FINAL. 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 JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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