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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/30/2026 has been entered.
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 91-97, 99, 103, 106-107, and 109-116 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.
With respect to independent claim 91, the claim amended to recites “providing, via display or by emitting a verbal command, instructions to a rescuer to administer the CPR therapy, wherein the instructions comprise instructions to the rescuer to reposition the flap comprising the CPR sensor on the chest of the patient”. Within the original disclosure in paragraphs [0042], [0043], [0125], [0169]-[0173] and [0230], regarding commands, and paragraphs [0046], [0047], [0097]-[0105], [0169], [0170],[0184]-[0187], [0199] and [0250], regarding instructions, there isn’t any mentioned of such “a verbal command, instructions”, as claimed.
With respect to independent claim 111, the claim amended to recite “providing, using the output device, instructions for a rescuer to unfold the flap to which the CPR sensor is coupled away from the garment such that the flap is repositioned to the center of the chest of the patient”. Within the original disclosure in paragraphs [0042], [0043], [0125], [0169]-[0173] and [0230], regarding commands, and paragraphs [0046], [0047], [0097]-[0105], [0169], [0170],[0184]-[0187], [0199] and [0250], regarding instructions, there isn’t any mentioned of such “instructions for a rescuer ”, as claimed
With respect to dependent claims 92-97, 99, 103, 106-107, and 109-110, and 112-116, they are rejected based upon their dependency to respective independent claims 91 and 111.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 91-97, 99, 103, 106-107, and 109-116 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al US 2012/0158075 (“Kaib”) in view of Pavelka US 4,582,508 (“Pavelka”), Williams US 7,810,172 (Williams”), Centen et al US 2008/0171311(“Centen”), and Nova et al US 6,334,070 (“Nova”).
As per claim 91, Kaib discloses a wearable medical device (wearable medical device 100/100’)(Figs. 1A-2A; [0043]-[0059]), comprising:
a garment that includes a waistband configured to be worn about a torso of a patient (harness 110)(Figs. 1A and 1B; [0045]);
a sensing electrode for receiving electrocardiogram signals indicative of cardiac activity in the patient (construed as any one of the sensor 112, i.e. “The plurality of ECG sensing electrodes 112)([0046]; also Figs. 1A and 1B; as well as [0050]);
a therapy electrode that is disposed in the garment and that is configured to apply a treatment shock to the torso of the patient (therapy electrodes 114a-114b)(Figs. 1A and 1B; [0046] and [0048]);
a CPR sensor, wherein the CPR sensor is for detecting a characteristic of a CPR therapy provided to the patient, (construed as either one of the sensor 112, that is not consider as the sensing electrode” i.e. “The plurality of ECG sensing electrodes 112, which may be dry-sensing capacitance electrodes, are used by the control unit 120 to monitor the cardiac function of the patient and generally include a front/back pair of ECG sensing electrodes and a side/side pair of ECG sensing electrodes”) and wherein the CPR sensor is positioned at a center of a chest of the patient (note at least Fig. 1B regarding such sensor located at, around a user’s center chest; and/or chest sensing device 130; “The connection pod 130 may also include other electronic circuitry, such as a motion sensor or accelerometer by which patient activity may be monitored”[0046]; also Figs. 1A and 1B; as well as [0050]);
an output device (audible means via loudspeaker)([0047] and [0048]); and a processor configured (of control unit 120)(Figs. 1A and [0047]-[0049]) for
determining that the patient is experiencing a cardiac arrhythmia based on the received electrocardiogram signals (at least [0048] ”The at least one processor of the control unit 120 is configured to monitor the patient's medical condition, to perform medical data logging and storage, and to provide medical treatment to the patient in response to a detected medical condition, such as cardiac arrhythmia”); providing, using the output device, an initial indication to the patient (at least [0047]”Where the control unit 120 determines that the patient is experiencing cardiac arrhythmia, the control unit 120 may issue an audible alarm via a loudspeaker (not shown) on the control unit 120 and/or the user interface pod 140 alerting the patient and any bystanders to the patient's medical condition.”);
processing information from the CPR sensor and providing, to the output device, information about the CPR therapy provided to the patient (processor of control unit 120)(Figs. 1A and 1B;[0047]- [0049]; e.g., “The user interface pod 140 typically includes one or more buttons by which the patient, or a bystander can communicate with the control unit 120, and a speaker by which the control unit 120 may communicate with the patient or the bystander.” ([0047] and “If the patient does not respond, the device may presume that the patient is unconscious, and proceed with the treatment sequence, culminating in the delivery of one or more defibrillating shocks to the body of the patient.” ([0048])).
Kaib is not specific regarding the waistband having attached thereto a flap, wherein the flap comprises a CPR sensor, and wherein the flap is capable of folding between (1) a first position in which the flap is positioned on the waistband and (2) a second position in which the flap is unfolded away from the waistband.
Kaib is not specific regarding, wherein the CPR sensor is positioned at the center of the chest of the patient when the flap is in the second position.
Kaib is not specific regarding making a first determination, based on the received electrocardiogram signals, whether the cardiac arrhythmia is non-shockable by the wearable medical device, in response to the first determination resulting in an indication that the cardiac arrhythmia is non-shockable by the wearable medical device; providing, via display or by emitting a verbal command, instructions to a rescuer to administer the CPR therapy, wherein the instructions comprise instructions to the rescuer to reposition the flap comprising the CPR sensor on the chest of the patient; determining, based on the processed information, whether chest compressions are occurring and whether the CPR sensor is positioned at the center of the chest of the patient, in response to detecting an absence of the chest compressions or improper positioning of the CPR sensor, providing, using the output device, feedback to assist in delivering effective CPR ,providing, using the output device, real-time guidance based on the processed information from the CPR sensor, the guidance comprising feedback related to at least one of a chest compressions rate or a chest compressions depth, after detecting information from the CPR sensor indicative of the CPR therapy having been applied to the patient, making a second determination, based on the received electrocardiogram signals, that the cardiac arrhythmia is shockable by the wearable medical device, and in response to the second determination resulting in an indication that the cardiac arrhythmia is shockable by the wearable medical device, providing, using the output device, an indication that the treatment shock is about to be delivered to the patient.
With respect to “the waistband having attached thereto a flap, wherein the flap is capable of folding between (1) a first position in which the flap is positioned on the waistband and (2) a second position in which the flap is unfolded away from the waistband”, in a similar field of wearable medical devices, Pavelka discloses a flap 12 attached to waistband 11, of a garment 13 that is configure worn about a torso of a patient (Figs. 1 and 2; 2:24+); the flap is capable of folding between a first position in which the flap is positioned on the waistband (Fig. 1) and a second position in which the flap is unfolded away from the waistband (Fig. 2). position/folding between a first position (e.g. Fig. 1) and a second position at a patient’s chest (Fig. 2). Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s waistband having attached thereto a flap, wherein the flap is capable of folding between (1) a first position in which the flap is positioned on the waistband and (2) a second position in which the flap is unfolded away from the waistband for the reason that a skilled artisan would have been motivated in using known mechanical means/attachment that facilitate holding, supporting, and storing medical devices with the worn garment, as suggested by Pavelka (e.g., 1:59+).
Kaib by, the teachings of Pavelka, is not specific regarding wherein the flap comprises a CPR sensor. However, in a similar field of wearable garments’ medical devices, Williams discloses a wearable garment comprising a flap (garment panel 12 having a medical device coupled thereto, via pocket 13; (note at least 2:61+ that the medical device is “a cardiac monitor”, i.e., CPR sensor) positioned between first position (Fig. 4) and second position (Fig. 2). Thus, Williams discloses wherein the flap comprises a CPR sensor. Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib- Pavelka’s wherein the flap comprises a CPR sensor for the reason that a skilled artisan would have been motivated by Williams’ suggestion that such garment structure is suitable to hold medical devices as needed (e.g., 1:28+ “The present invention provides a garment for accommodating medical devices comprising a garment body detachably coupled to a panel containing a concealed pocket for accommodating a medical device”). Within the modified Kaib- Pavelka- Williams, the CPR sensor (as taught by Kaib and/or Williams) would have been positioned at the center of the chest of the patient (as taught by Kaib) when the flap is in the second position (as taught by Pavelka- Williams).
With regard to determining, based on the processed information, whether chest compressions are occurring and whether the CPR (Centen in Figs. 1-2, and 11-14 in conjunction to [0040]-[0048], [0098]-[0128] and [0135]-[0157]; e.g., Figs. 13-14 [0142]-[0145]) and, in response to detecting an absence of chest compressions or improper positioning of the CPR sensor (Figs. 13 and 14; [0141]+; note steps 108-112), providing, using the output device, feedback to assist in delivering effective CPR(Figs. 13 and 14; [0141]+; note steps 108-112) ,providing, using the output device, real-time guidance based on the processed information from the CPR sensor (Figs. 13 and 14; [0141]+; note steps 108-112; also [0139]+), the guidance comprising feedback related to at least one of a rate or a depth of chest compressions (Figs. 13 and 14; [0141]+; note steps 108-112; e.g. step 110 and [0147]), providing, to the output device, information about the CPR therapy provided to the patient, after detecting information from the CPR sensor indicative of the CPR therapy having been applied to the patient (Figs. 13 and 14; [0141]+; note steps 108-112), making a second determination, based on the received electrocardiogram signals, whether the cardiac arrhythmia is shockable or non-shockable by the wearable medical device(Figs. 13 and 14; [0141]+; note steps 108-112; steps 126-130; par. [0150]+ if a defibration is require), and in response to the second determination resulting in an indication that the cardiac arrhythmia is shockable by the wearable medical device, providing, using the output device, an indication that the treatment shock is about to be delivered to the patient (Figs. 13 and 14; [0141]+; note steps 108-112; e.g. steps128-130). Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s device to further determining, based on the processed information, whether chest compressions are occurring and whether the CPR sensor is positioned at the center of the chest of the patient, in response to detecting an absence of chest compressions or improper positioning of the CPR sensor, providing, using the output device, feedback to assist in delivering effective CPR ,providing, using the output device, real-time guidance based on the processed information from the CPR sensor, the guidance comprising feedback related to at least one of a rate or a depth of chest compressions, providing, to the output device, information about the CPR therapy provided to the patient, after detecting information from the CPR sensor indicative of the CPR therapy having been applied to the patient, making a second determination, based on the received electrocardiogram signals, whether the cardiac arrhythmia is non-shockable by the wearable medical device, and in response to the second determination resulting in an indication that the cardiac arrhythmia is shockable by the wearable medical device, providing, using the output device, an indication that the treatment shock is about to be delivered to the patient for the reason that a skilled artisan would have been motivated in using known technology while provide instruction for carrying out a proper CPR procedure for training, testing, and/or emergency situations. Such a device may be intuitive to use (Centen’s [0018]). Such data within the device of Kaib is much desired and enhance his data information regarding a patient medical situation.
In addition, with respect to sensor being positioned at the center of the chest of the patient, within the modified Kaib, by at least the teachings of Williams, while the flap in the second position the flap (with the CPR sensor) it would have been positioned at such location (e.g., Williams Fig. 2). In addition, note Centen’s [0158] ”The positions of the sensors may be modified by the CPR performer so as to suit the specific application, or the sensors may be interchangeable.” Thus, positioning the CPR sensor at the center of a patient’s chest would have been in such suitable position as suggested by Centen.
Also, with respect to the CPR sensor, the examiner construed Kaib’s accelerometer as the CPR sensor according to applicant’s original disclosure. In at least [0125] and [0153] it states “a garment configured to be worn about a torso of a patient and one or more sensors (e.g., including one or more accelerometers) for detecting characteristics of a cardiopulmonary resuscitation (CPR) therapy administered to the patient. For example, while a user is administering CPR to the patient, an accelerometer” and “The CPR sensor 140 may include one or more accelerometers that are configured to detect motion that occurs during the administration of CPR.” However, if there is any doubt regarding such interpretation, the examiner notes that the use of a CPR sensor, with a wearable, garment is well known as taught Centen (garment 2 with CPR sensing/performing means 4/16-18-20-22) (Figs. 2-2 and [0040]-[0066]; note also Figs. 2 and 12 in conjunction to [0089]-[0094] regarding a processing unit and [0098]-[0105] a feedback unit). Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s with a CPR sensor for detecting a characteristic of a CPR therapy provided to the patient; and a processor configured for processing information from the CPR sensor and providing, to the output device, information about the CPR therapy provided to the patient as taught by Centen for the reason that a skilled artisan would have been motivated to include such CPR sensor (connected to a processor and output means) with a wearable garment as be desirable to provide an easy-to-use and inexpensive device to provide instruction for carrying out a proper CPR procedure for training, testing, and/or emergency situations. Such a device may be intuitive to use (Centen’s [0018]). In addition, consider, Kaib’s [0050] ”Although not shown, the wearable medical device 100 may include additional sensors, other than the ECG sensing electrodes 112, capable of monitoring the physiological condition or activity of the patient. For example, sensors capable of measuring blood pressure, heart rate, heart sounds, thoracic impedance, pulse oxygen level, respiration rate, and the activity level of the patient may also be provided.” Thus, such CPR sensor-to output device-to processor would have been such means for monitoring the physiological condition or activity of the patient, as suggested by Kaib.
With respect to , providing, via display or by emitting a verbal command, instructions to a rescuer to administer the CPR therapy, wherein the instructions comprise instructions to the rescuer to reposition the flap comprising the CPR sensor on the chest of the patient, in similar field of medical devices to administer a CPR, Nova discloses an AED device 10/10’ comprising a display 14/14’ in communication with a microprocessor 24 (Figs. 1A-2; 3:38-5:24); the device provided instructions/commands to a rescuer, via the display and audio (speaker 18/18’)(note Figs. 7-9, 10H and 10G in conjunction to at least 8:46-15:60, as the device provides visual and verbal instructions to a rescuer to assess a patina’s conditions and to follow the instructions/commands; e.g., note 11:5+ “Although not shown, if the electrodes 16 are sealed within an electrode package, an additional visual instruction may be displayed for the electrode package opening action. Simultaneously with the visual instruction, a verbal instruction is issued via the speaker 18 to "Apply Adhesive Pads to Bare Chest” (equivalent to instructions/commands to reposition the CPR sensor (which is within the flap) to a patient’s chest). Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form the modified Kaib’s providing, via display or by emitting a verbal command, instructions to a rescuer to administer the CPR therapy, wherein the instructions comprise instructions to the rescuer to reposition the flap comprising the CPR sensor on the chest of the patient for the reason that a skilled artisan would have been motivated by Nova’s suggestions to use visible and verbal instructions/commands to assist in assessing a patina’s condition (e.g., 2:3+”Consequently, a defibrillator is needed which is capable of successfully directing precise instructions to a first responder with minimal or no training through a cardiorespiratory event, i.e., CPR as well as AED device operation, by use of visual and aural instructions. The defibrillator should be as simple and user friendly as possible so as to remove any impediment to use by a rescuer with minimal or no training. Further, the defibrillator should be programmable so as to comply with any changes in the standard protocols for CPR and AED operation”).
As per claim 92, with respect to wherein: the flap is attached to the waistband along a seam, note Pavelka’s Figs. 1-4 regarding flap/pouch 12 attached to waistband 11 (also, 3:4-10). Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s the flap is attached to the waistband along a seam for similar reasons discussed above with respect to claim 91.
As per claim 93, with respect to wherein: when the flap is in the second position, the CPR sensor above a xiphoid process of the patient, within the modified Kaib-Pavelka the CPR sensor (as taught by Kaib) position within flap of Pavelka in the second position it would have been position at such location (e.g., Pavelka’s Fig. 2; also as shown in Williams’ Fig. 2). Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s the flap is in the second position, the CPR sensor above a xiphoid process of the patient for similar reasons discussed above with respect to claim 91.
As per claim 94, with respect to wherein the characteristic of the CPR therapy comprises one or more of the chest compression depth or the chest compression rate, note Centen’s [0019], [0059], [0061], [0063]-[0067], [0069] and [0070]. Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s wherein the characteristic of the CPR therapy comprises one or more of the chest compression depth or the chest compression rate for similar reasons discussed above with respect to claim 91.
As per claim 95, with respect to wherein the CPR sensor is coupled to flap using a hook-and-loop fastener, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form such connecting as using known mechanical means/ fastening to insure the CPR sensor firmly attached to the flap yet can be remove for replacement, maintenance and alike.
As per claim 96, with respect to wherein the instructions to the rescuer to administer the CPR therapy are provided after determining that the CPR sensor is positioned at the center of the chest of the patient, note Kaib’s [0048] as well as Centen’s Figs. 2, 13 and 14; [0045], [0098]-[0105] regarding the use of a output device (i.e., feedback device) to instruct a user to use the device; note for example Fig. 13 and [0141]-[0149] as data receiving regarding patient’s cardiac condition to administer, or not, a CPR). With respect to the CPR sensor means, note the examiner discussion above with respect to claim 91. Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s wherein the indication that the CPR therapy should be administered to the patient is provided after determining that the CPR sensor is positioned at the center of the chest of the patient for the reason that a skilled artisan would have been motivated in applying a known technique to a known device as a logical manner to determine, based upon the CPR sensor data, that position at a patient’s center of the chest (as the flap, with the CPR sensor at such position), to the correct procedure require for the CPR therapy.
As per claim 97, with respect to wherein: the garment further comprises a shoulder strap, note Kaib’s Figs. 1A and 1B ([0045]).
As per claim 99, with respect to wherein the flap pivots along the seam when the flaps moves between the first position and the second position, note Pavelka’s Fig. 1 position of flap 12 (i.e. first position) and pivots to a second position (Fig. 2) via/along the seam therebetween the flap and waistband 11 (see also 3:4-10). See also Williams’ Figs. 2 and 4 and 6:55-7:51 as the flap (panel 12) pivots along attachment zone 16. Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s flap pivots along the seam when the flaps moves between the first position and the second position for similar reasons discussed above with respect to claim 91.
As per claim 103, with respect to wherein the CPR sensor is attached to the flap using a snap fastener, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to use of known mechanical fasteners (e.g., snap fastener) to insure the CPR sensor firmly attached to the flap yet can be remove for replacement, maintenance and alike.
As per claim 106, with respect to wherein the waistband is positioned over a rib of the patient when the patient wears the garment, note Kaib’s Figs. 1A and 1B.
As per claim 107, with respect to wherein the characteristic of the CPR therapy comprises one or more of the chest compression depth or the chest compression rate, note Centen’s [0019], [0059], [0061], [0063]-[0067], [0069] and [0070]. Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s wherein the characteristic of the CPR therapy comprises one or more of the chest compression depth or the chest compression rate for similar reasons discussed above with respect to claim 91.
As per claim 109, with respect to wherein the instructions to the rescuer to administer the CPR therapy are provided after determining that the CPR sensor is positioned at the center of the chest of the patient, note Kaib’s [0048] as well as Centen’s Figs. 2, 13 and 14; [0045], [0098]-[0105] regarding the use of a output device (i.e., feedback device) to instruct a user to use the device; note for example Fig. 13 and [0141]-[0149] as data receiving regarding patient’s cardiac condition to administer, or not, a CPR. Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s wherein the indication that the CPR therapy should be administered to the patient is provided after determining that the CPR sensor is positioned at the center of the chest of the patient for the reason that a skilled artisan would have been motivated in applying a known technique to a known device as a logical manner to determine, based upon the CPR sensor data position at a patient’s center of the chest (as the flap, with the CPR sensor as such position), to the correct procedure require for the CPR therapy.
As per claim 110, with respect to wherein the CPR sensor is configured to wirelessly communicate with the processor, note Centen’s [0053], [0090], [0093], [0099], [0106]-[0110], [0126], [0127], and [0137]; also note Kaib’s [0016], [0020], [0078], [0079], [0085], [0087] and [0088] regarding wireless communication. Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s wherein the CPR sensor is configured to wirelessly communicate with the processor for similar reasons discussed above with respect to claim 91.
As per claim 111, since the claim’s limitations are very similar to claim 91, the examiner states that claim 111 is rejected over Kaib, Pavelka, Williams , Centen and Nova for the same reasons discussed above with respect to claim 91. Since there is no apparent different structural and/or functional limitations of the device of claim 91 and the device of claim 111, it is important to note that such statement by the examiner is not merely to “ignore” the claim’s limitations; rather, the examiner attempts to simplify the above rejection, and not “paste and copy” similar limitations, thus, to create unnecessary lengthy Office action. The examiner construed “a CPR sensor for detecting a characteristic of a CPR therapy provided to the patient, the CPR sensor being configured to be positioned at a center of a chest of the patient when the CPR therapy is provided to the patient” as the flap f a waistband with a flap moves between first and second positions to be place upon a user’s center of a chest (as taught by Pavelka) whereas the flap is provide with a CPR sensor (as taught by Williams).
More specific with regard to “providing, using the output device, instructions for a rescuer to unfold the flap to which the CPR sensor is coupled away from the garment such that the flap is repositioned to the center of the chest of the patient”, note Nova’s Figs. 7-9, 10H and 10G in conjunction to at least 8:46-15:60, as the device provides visual and verbal instructions to a rescuer to assess a patina’s conditions and to follow the instructions/commands; e.g., note 11:5+ “Although not shown, if the electrodes 16 are sealed within an electrode package, an additional visual instruction may be displayed for the electrode package opening action. Simultaneously with the visual instruction, a verbal instruction is issued via the speaker 18 to "Apply Adhesive Pads to Bare Chest” (equivalent to instructions to reposition the CPR sensor (which is within the flap) to a patient’s chest).
With respect to “providing, using the output device, an indication that the CPR therapy should be administered to the patient, once the CPR sensor is repositioned to the center of the chest of the patient, providing, using the output device, instructions for the rescuer to begin chest compressions,”, note Nova’s Figs. 9, 10g in conjunction to at least 14:16+”Returning now to FIG. 3, after the patient's condition has been assessed by the rescuer, the rescuer has attached the defibrillation electrodes 16 to the patient, and the patient's heart rhythm has been monitored for a shockable heart rhythm such as ventricular fibrillation, the logic proceeds to a block 126 where the CPR delivery sequence is initiated by the user interface program 22. The CPR delivery sequence is shown in more detail in FIG. 9. The logic in FIG. 9 begins in a block 230 and proceeds to a block 232 where the rescuer is instructed to deliver a predetermined or p number of chest compressions to the patient. More specifically, the visual instruction for delivering chest compression shown in FIG. 10G is generated on the display 14 of the AED 10.”
Within the modified Kaib, the CPR sensor would have been within the flap (as taught by Pavelka- Williams) to be placed upon a patient’s chest (as taught by Kaib- Centen- Nova).
As per claim 112, with respect to wherein, wherein the indication that the CPR therapy should be administered to the patient is provided after, determining that the CPR sensor is positioned at the center of the chest of the patient, note Kaib’s [0048] as well as Centen’s Figs. 2, 13 and 14; [0045], [0098]-[0105] regarding the use of a output device (i.e., feedback device) to instruct a user to use the device; note for example Fig. 13 and [0141]-[0149] as data receiving regarding patient’s cardiac condition to administer, or not, a CPR). Note, Centen’s Fig. 13 in conjunction [0141]+ as the use of his device and to determine shock or non-shock operation upon a user’s cardiac state , i.e., determining that the patient is experiencing bradycardia or asystole. Also, note Centen’s [0158] as the position of the sensor can be in any suitable location to read/sense the cardiac condition of the patient. With respect to the CPR sensor means, note the examiner discussion above with respect to claim 91. Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s wherein the indication that the CPR therapy should be administered to the patient is provided after, determining that the CPR sensor is positioned at the center of the chest of the patient for the reason that a skilled artisan would have been motivated in applying a known technique to a known device as a logical manner to determine, based upon the CPR sensor data, that position at a patient’s center of the chest (as the flap, with the CPR sensor at such position), to the correct procedure require for the CPR therapy.
As per claim 113, with respect to wherein the garment includes: a shoulder strap.
note Kaib’s Figs. 1A and 1B ([0045]) regarding harness 110.
As per claim 114, with respect to wherein the garment has attached thereto a pocket that is positioned on the waistband of the garment, note Williams’s Figs. 1, 2, 3A and 4 regarding pocket 13 attached to garment 10. Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s wherein the garment has attached thereto a pocket that is positioned on the waistband of the garment for the reason that a skilled artisan would have been motivated is applying a known technique to a known device to attached a pocket to a garment configure to hold the CPR sensor in a safe and concealed position yet allow easy access thereto to be remove and be place upon a user’s center chest for any require CPR therapy.
As per claim 115, with respect to wherein the pocket is configured to receive the CPR sensor when the flap is in the first position, note at least Williams’ Fig. 4 (regarding pocket 13) as well as Pavelka’s Fig. 1 as the flap in a first position (i.e., positioned on the waistband). Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s wherein the pocket is configured to receive the CPR sensor when the flap is in the first position for the reason that a skilled artisan would have been motivated is applying a known technique to a known device to attached a pocket to a garment configure to hold the CPR sensor in a safe and concealed position yet allow easy access thereto to be remove and be place upon a user’s center chest for any require CPR therapy, while the pocket is attached to the waistband as a user wears the medical device.
As per claim 116, with respect to wherein the CPR sensor is positioned at the center of the chest of the patient when the flap is in the second position, note Williams’s Figs. 1 and 2 as the flap/pocket (with a c CPR sensor) in a second position, as well as Pavelka’s Fig. 2 as the flap in a second position (at user’s center of the chest). Therefore, the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to form Kaib’s wherein the CPR sensor is positioned at the center of the chest of the patient when the flap is in the second position for the reason that a skilled artisan would have been motivated in applying a known technique to a known device as a logical manner to determine, based upon the CPR sensor data, that position at a patient’s center of the chest (as the flap, with the CPR sensor at such position), to the correct procedure require for the CPR therapy.
Response to Arguments
Applicant’s arguments with respect to claim(s) 91-97, 99, 103, 106-107 and 109-116 have been considered but are partially moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument and they are partially not persuasive.
With respect to claim 91, applicant stated “among other things, "providing, via display or by emitting a verbal command, instructions to a rescuer to administer the CPR therapy, wherein the instructions comprise instructions to the rescuer to reposition the flap comprising the CPR sensor on the chest of the patient", "determining, based on [processed information from the CPR sensor], whether chest compressions are occurring and whether the CPR sensor is positioned at the center of the chest of the patient", and "in response to detecting an absence of the chest compressions or improper positioning of the CPR sensor, providing, using the output device, feedback to assist in delivering effective CPR” (remarks page 8).
With respect to "providing, via display or by emitting a verbal command, instructions to a rescuer to administer the CPR therapy, wherein the instructions comprise instructions to the rescuer to reposition the flap comprising the CPR sensor on the chest of the patient", applicant’s arguments are moot as such new limitations are taught by the reference to Nova as set forth above.
With respect to "determining, based on [processed information from the CPR sensor], whether chest compressions are occurring and whether the CPR sensor is positioned at the center of the chest of the patient", such limitations are taught by Centen in Figs. 1-2, and 11-14 in conjunction to [0040]-[0048], [0098]-[0128] and [0135]-[0157]; e.g., Figs. 13-14 [0142]-[0145]). With respect to "in response to detecting an absence of the chest compressions or improper positioning of the CPR sensor, providing, using the output device, feedback to assist in delivering effective CPR”, as set forth above, Centen in Figs. 13 and 14; [0141]+; note steps 108-112, (providing, using the output device, feedback to assist in delivering effective CPR)(Figs. 13 and 14; [0141]+; note steps 108-112), discloses such limitations.
With respect to claim 111, applicant stated “among other things, “providing, using the output device, instructions for a rescuer to unfold the flap to which the CPR sensor is coupled away from the garment such that the flap is repositioned to the center of the chest of the patient", "providing, using the output device, an indication that the CPR therapy should be administered to the patient", and "once the CPR sensor is repositioned to the center of the chest of the patient, providing, using the output device, instructions for the rescuer to begin chest compressions".(remarks page 9).
With regard to "providing, using the output device, instructions for a rescuer to unfold the flap to which the CPR sensor is coupled away from the garment such that the flap is repositioned to the center of the chest of the patient", and "once the CPR sensor is repositioned to the center of the chest of the patient, providing, using the output device, instructions for the rescuer to begin chest compressions", such new limitations are taught by the reference to Nova as set forth above.
With respect to “providing, using the output device, an indication that the CPR therapy should be administered to the patient” note Centen’s Fig. 13 in conjunction to [0144]-[0146]” At a step 106, a heart rate is not detected. This may be conveyed to the performer, and the performer may be instructed to carry out CPR on the patient. At a step 108, the performer is instructed to place hands over the patient's sternum in preparation for performing CPR. The device may provide visual and/or audio feedback to aid the performer to provide chest compressions at a desired rate.”
Conclusion
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/A.A.K/Examiner, Art Unit 3711 9/1/2026 /JOHN E SIMMS JR/Primary Examiner, Art Unit 3711
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